Job DescriptionJob Description About Drivemode: Drivemode is a California-based division of Honda Motor Co., Ltd. We are a small, passionate team of software product innovators helping Honda Automotive be competitive in the Hybrid and Electric Vehicle market. We build application experiences for mobile devices. Are you passionate about creating next-generation delightful digital experiences for automotive? Maybe you have worked at some notable automotive companies in this capacity? Would you like to work on new products and product categories at Honda and help Honda invent the future of automotive? Then we would like to hear from you! Why Drivemode: Join Drivemode for an exciting startup environment and a vibrant culture that combines impactful work, competitive compensation, and excellent benefits. By becoming a part of our team, you'll contribute to a crucial mission that revolutionizes the way people engage with vehicles, addressing both business needs and the world's environmental challenges. This presents an exceptional opportunity to be at the forefront of innovation and drive Honda's success in the Automotive market. About the Role: You'll be the manager responsible for the QA team, including processes, test planning, and test automation to ensure the quality of our mobile app meets the high standards Honda is setting with their new line of vehicles. You will work closely with Product Managers, Engineers, and Stakeholders throughout the Honda organization. Your team will test mobile app interactions on both iOS and Android across APIs and through to automotive hardware. You will aid us in leveling up the QA team to ensure the highest quality interactions for Honda drivers. We're looking for someone who has a strong sense of ownership of product features and quality, is enthusiastic about trying new technologies, and does not hesitate to do whatever it takes to get things done, even if outside your usual responsibility area. Responsibilities: Lead, mentor, and manage the quality assurance team and foster their professional growth Develop, implement, and manage quality assurance protocols and strategies to ensure quality meets international and internal standards Drive continuous improvement in QA processes and tooling including resilient automated testing and simulated/mock dependencies Oversee the design, creation, and review process of test cases and ensure they are comprehensive and align with product specifications Collaborate closely with product development teams to understand and review product specifications and requirements, ensuring QA processes are aligned with objectives Establish and maintain communication channels between relevant internal and external stakeholders such as vehicle hardware teams and tier-1 suppliers Thoroughly plan vehicle/hardware tests in coordination with external QA teams to ensure efficient and productive testing sessions Report directly to the senior management on quality assurance metrics, progress, and team performance Ensure compliance with industry standards and regulatory requirements Manage the QA team's test plans and travel to on-site testing at facilities in Japan, Ohio and Los Angeles. Qualifications: 7+ years of experience in Quality Assurance 3+ years in a QA management role Deep understanding of the SDLC Proven track record leading QA teams and managing comprehensive testing strategies for both software and hardware Strong leadership and excellent verbal, written, and presentation skills Proficiency with testing for mobile applications on Android and iOS Proficiency building and maintaining test automation for mobile applications Able to understand and analyze technical documentation Able to understand API specifications and configure standard tooling (Postman, etc) to test against them Experience planning and developing test strategies to meet project targets Experience standardizing and improving QA processes Nice to Have: Proficiency with testing Controller Area Network (CAN), LIN, and Ethernet Experience with embedded systems testing Certifications such as ISTQB or an equivalent certificate Agile experience Bluetooth testing experience This reflects the base salary for the position. In addition, the role offers a comprehensive benefits package and a progressive bonus program. The actual compensation package is determined by a variety of factors unique to each candidate, including demonstrated skills, depth and relevance of experience, and role-specific considerations. We welcome open conversations about compensation during initial discussions with all candidates. EEOC Statement Drivemode is proud of a very diverse team with employees coming from 5 continents/20 countries as of today. Diversity in our workplace has played an important part in our success; we recognize each employee's unique background, knowledge, experiences, ideas, and viewpoints which are all critical in developing a product that has the greatest impacts on drivers all over the world. Drivemode provides equal opportunities to all employees and applicants for employment without regard to race, religion, color, age, gender, national origin, sexual orientation, gender identity, disability, or any other characteristics that make you unique.
09/25/2026
Full time
Job DescriptionJob Description About Drivemode: Drivemode is a California-based division of Honda Motor Co., Ltd. We are a small, passionate team of software product innovators helping Honda Automotive be competitive in the Hybrid and Electric Vehicle market. We build application experiences for mobile devices. Are you passionate about creating next-generation delightful digital experiences for automotive? Maybe you have worked at some notable automotive companies in this capacity? Would you like to work on new products and product categories at Honda and help Honda invent the future of automotive? Then we would like to hear from you! Why Drivemode: Join Drivemode for an exciting startup environment and a vibrant culture that combines impactful work, competitive compensation, and excellent benefits. By becoming a part of our team, you'll contribute to a crucial mission that revolutionizes the way people engage with vehicles, addressing both business needs and the world's environmental challenges. This presents an exceptional opportunity to be at the forefront of innovation and drive Honda's success in the Automotive market. About the Role: You'll be the manager responsible for the QA team, including processes, test planning, and test automation to ensure the quality of our mobile app meets the high standards Honda is setting with their new line of vehicles. You will work closely with Product Managers, Engineers, and Stakeholders throughout the Honda organization. Your team will test mobile app interactions on both iOS and Android across APIs and through to automotive hardware. You will aid us in leveling up the QA team to ensure the highest quality interactions for Honda drivers. We're looking for someone who has a strong sense of ownership of product features and quality, is enthusiastic about trying new technologies, and does not hesitate to do whatever it takes to get things done, even if outside your usual responsibility area. Responsibilities: Lead, mentor, and manage the quality assurance team and foster their professional growth Develop, implement, and manage quality assurance protocols and strategies to ensure quality meets international and internal standards Drive continuous improvement in QA processes and tooling including resilient automated testing and simulated/mock dependencies Oversee the design, creation, and review process of test cases and ensure they are comprehensive and align with product specifications Collaborate closely with product development teams to understand and review product specifications and requirements, ensuring QA processes are aligned with objectives Establish and maintain communication channels between relevant internal and external stakeholders such as vehicle hardware teams and tier-1 suppliers Thoroughly plan vehicle/hardware tests in coordination with external QA teams to ensure efficient and productive testing sessions Report directly to the senior management on quality assurance metrics, progress, and team performance Ensure compliance with industry standards and regulatory requirements Manage the QA team's test plans and travel to on-site testing at facilities in Japan, Ohio and Los Angeles. Qualifications: 7+ years of experience in Quality Assurance 3+ years in a QA management role Deep understanding of the SDLC Proven track record leading QA teams and managing comprehensive testing strategies for both software and hardware Strong leadership and excellent verbal, written, and presentation skills Proficiency with testing for mobile applications on Android and iOS Proficiency building and maintaining test automation for mobile applications Able to understand and analyze technical documentation Able to understand API specifications and configure standard tooling (Postman, etc) to test against them Experience planning and developing test strategies to meet project targets Experience standardizing and improving QA processes Nice to Have: Proficiency with testing Controller Area Network (CAN), LIN, and Ethernet Experience with embedded systems testing Certifications such as ISTQB or an equivalent certificate Agile experience Bluetooth testing experience This reflects the base salary for the position. In addition, the role offers a comprehensive benefits package and a progressive bonus program. The actual compensation package is determined by a variety of factors unique to each candidate, including demonstrated skills, depth and relevance of experience, and role-specific considerations. We welcome open conversations about compensation during initial discussions with all candidates. EEOC Statement Drivemode is proud of a very diverse team with employees coming from 5 continents/20 countries as of today. Diversity in our workplace has played an important part in our success; we recognize each employee's unique background, knowledge, experiences, ideas, and viewpoints which are all critical in developing a product that has the greatest impacts on drivers all over the world. Drivemode provides equal opportunities to all employees and applicants for employment without regard to race, religion, color, age, gender, national origin, sexual orientation, gender identity, disability, or any other characteristics that make you unique.
Job DescriptionJob Description About Drivemode: Drivemode is a California-based division of Honda Motor Co., Ltd. We are a small, passionate team of software product innovators helping Honda Automotive be competitive in the Hybrid and Electric Vehicle market. We build application experiences for mobile devices. Are you passionate about creating next-generation delightful digital experiences for automotive? Maybe you have worked at some notable automotive companies in this capacity? Would you like to work on new products and product categories at Honda and help Honda invent the future of automotive? Then we would like to hear from you! Why Drivemode: Join Drivemode for an exciting startup environment and a vibrant culture that combines impactful work, competitive compensation, and excellent benefits. By becoming a part of our team, you'll contribute to a crucial mission that revolutionizes the way people engage with vehicles, addressing both business needs and the world's environmental challenges. This presents an exceptional opportunity to be at the forefront of innovation and drive Honda's success in the Automotive market. About the Role: You'll be the manager responsible for the QA team, including processes, test planning, and test automation to ensure the quality of our mobile app meets the high standards Honda is setting with their new line of vehicles. You will work closely with Product Managers, Engineers, and Stakeholders throughout the Honda organization. Your team will test mobile app interactions on both iOS and Android across APIs and through to automotive hardware. You will aid us in leveling up the QA team to ensure the highest quality interactions for Honda drivers. We're looking for someone who has a strong sense of ownership of product features and quality, is enthusiastic about trying new technologies, and does not hesitate to do whatever it takes to get things done, even if outside your usual responsibility area. Responsibilities: Lead, mentor, and manage the quality assurance team and foster their professional growth Develop, implement, and manage quality assurance protocols and strategies to ensure quality meets international and internal standards Drive continuous improvement in QA processes and tooling including resilient automated testing and simulated/mock dependencies Oversee the design, creation, and review process of test cases and ensure they are comprehensive and align with product specifications Collaborate closely with product development teams to understand and review product specifications and requirements, ensuring QA processes are aligned with objectives Establish and maintain communication channels between relevant internal and external stakeholders such as vehicle hardware teams and tier-1 suppliers Thoroughly plan vehicle/hardware tests in coordination with external QA teams to ensure efficient and productive testing sessions Report directly to the senior management on quality assurance metrics, progress, and team performance Ensure compliance with industry standards and regulatory requirements Manage the QA team's test plans and travel to on-site testing at facilities in Japan, Ohio and Los Angeles. Qualifications: 7+ years of experience in Quality Assurance 3+ years in a QA management role Deep understanding of the SDLC Proven track record leading QA teams and managing comprehensive testing strategies for both software and hardware Strong leadership and excellent verbal, written, and presentation skills Proficiency with testing for mobile applications on Android and iOS Proficiency building and maintaining test automation for mobile applications Able to understand and analyze technical documentation Able to understand API specifications and configure standard tooling (Postman, etc) to test against them Experience planning and developing test strategies to meet project targets Experience standardizing and improving QA processes Nice to Have: Proficiency with testing Controller Area Network (CAN), LIN, and Ethernet Experience with embedded systems testing Certifications such as ISTQB or an equivalent certificate Agile experience Bluetooth testing experience This reflects the base salary for the position. In addition, the role offers a comprehensive benefits package and a progressive bonus program. The actual compensation package is determined by a variety of factors unique to each candidate, including demonstrated skills, depth and relevance of experience, and role-specific considerations. We welcome open conversations about compensation during initial discussions with all candidates. EEOC Statement Drivemode is proud of a very diverse team with employees coming from 5 continents/20 countries as of today. Diversity in our workplace has played an important part in our success; we recognize each employee's unique background, knowledge, experiences, ideas, and viewpoints which are all critical in developing a product that has the greatest impacts on drivers all over the world. Drivemode provides equal opportunities to all employees and applicants for employment without regard to race, religion, color, age, gender, national origin, sexual orientation, gender identity, disability, or any other characteristics that make you unique.
09/25/2026
Full time
Job DescriptionJob Description About Drivemode: Drivemode is a California-based division of Honda Motor Co., Ltd. We are a small, passionate team of software product innovators helping Honda Automotive be competitive in the Hybrid and Electric Vehicle market. We build application experiences for mobile devices. Are you passionate about creating next-generation delightful digital experiences for automotive? Maybe you have worked at some notable automotive companies in this capacity? Would you like to work on new products and product categories at Honda and help Honda invent the future of automotive? Then we would like to hear from you! Why Drivemode: Join Drivemode for an exciting startup environment and a vibrant culture that combines impactful work, competitive compensation, and excellent benefits. By becoming a part of our team, you'll contribute to a crucial mission that revolutionizes the way people engage with vehicles, addressing both business needs and the world's environmental challenges. This presents an exceptional opportunity to be at the forefront of innovation and drive Honda's success in the Automotive market. About the Role: You'll be the manager responsible for the QA team, including processes, test planning, and test automation to ensure the quality of our mobile app meets the high standards Honda is setting with their new line of vehicles. You will work closely with Product Managers, Engineers, and Stakeholders throughout the Honda organization. Your team will test mobile app interactions on both iOS and Android across APIs and through to automotive hardware. You will aid us in leveling up the QA team to ensure the highest quality interactions for Honda drivers. We're looking for someone who has a strong sense of ownership of product features and quality, is enthusiastic about trying new technologies, and does not hesitate to do whatever it takes to get things done, even if outside your usual responsibility area. Responsibilities: Lead, mentor, and manage the quality assurance team and foster their professional growth Develop, implement, and manage quality assurance protocols and strategies to ensure quality meets international and internal standards Drive continuous improvement in QA processes and tooling including resilient automated testing and simulated/mock dependencies Oversee the design, creation, and review process of test cases and ensure they are comprehensive and align with product specifications Collaborate closely with product development teams to understand and review product specifications and requirements, ensuring QA processes are aligned with objectives Establish and maintain communication channels between relevant internal and external stakeholders such as vehicle hardware teams and tier-1 suppliers Thoroughly plan vehicle/hardware tests in coordination with external QA teams to ensure efficient and productive testing sessions Report directly to the senior management on quality assurance metrics, progress, and team performance Ensure compliance with industry standards and regulatory requirements Manage the QA team's test plans and travel to on-site testing at facilities in Japan, Ohio and Los Angeles. Qualifications: 7+ years of experience in Quality Assurance 3+ years in a QA management role Deep understanding of the SDLC Proven track record leading QA teams and managing comprehensive testing strategies for both software and hardware Strong leadership and excellent verbal, written, and presentation skills Proficiency with testing for mobile applications on Android and iOS Proficiency building and maintaining test automation for mobile applications Able to understand and analyze technical documentation Able to understand API specifications and configure standard tooling (Postman, etc) to test against them Experience planning and developing test strategies to meet project targets Experience standardizing and improving QA processes Nice to Have: Proficiency with testing Controller Area Network (CAN), LIN, and Ethernet Experience with embedded systems testing Certifications such as ISTQB or an equivalent certificate Agile experience Bluetooth testing experience This reflects the base salary for the position. In addition, the role offers a comprehensive benefits package and a progressive bonus program. The actual compensation package is determined by a variety of factors unique to each candidate, including demonstrated skills, depth and relevance of experience, and role-specific considerations. We welcome open conversations about compensation during initial discussions with all candidates. EEOC Statement Drivemode is proud of a very diverse team with employees coming from 5 continents/20 countries as of today. Diversity in our workplace has played an important part in our success; we recognize each employee's unique background, knowledge, experiences, ideas, and viewpoints which are all critical in developing a product that has the greatest impacts on drivers all over the world. Drivemode provides equal opportunities to all employees and applicants for employment without regard to race, religion, color, age, gender, national origin, sexual orientation, gender identity, disability, or any other characteristics that make you unique.
JOB DESCRIPTION Located in the metropolitan area of Sacramento, the Adventist Health corporate headquarters have been based in Roseville, California, for more than 40 years. In 2019, we unveiled our WELL-certified campus - a rejuvenating place for associates systemwide to collaborate, innovate and connect. Adventist Health Roseville and shared service teams have access to enjoy a welcoming space designed to promote well-being and inspire your best work. Job Summary: Adventist Health Roseville is seeking an Epic-Certified EHR Systems Analyst III for a full-time, day-shift position. We are looking for a strong candidate who can work primarily remotely, with the ability to travel up to 25% as required by the role. Candidates must have at least five (5) years of recent Epic Ambulatory experience. EpicCare Ambulatory certification is highly desirable , with a strong preference for candidates certified in Bones or Wisdom . Experience supporting Occupational Health or Occupational Medicine workflows in Epic is strongly preferred, including any exposure to the Epic Occupational Medicine (Occ Med) module . Leads the implementation and support of hospital information systems. Leads the planning, design, implementation, and maintenance of the existing systems and has a working knowledge of the applications for support and troubleshooting. Liaises between technical support, customers, and project teams in the design, implementation, and training of our healthcare information systems and any new enhanced systems. Utilizes comprehensive knowledge of Epic EHR system capabilities and functional use. Develops, recommends, and oversees implementation of policies and procedures for areas of responsibility. Job Requirements: Education and Work Experience: Bachelor's Degree or equivalent combination of education/related experience: Required Five years' healthcare IT application/technical experience: Required Five years' of applicable Epic application experience: Required Licenses/Certifications: Epic Certification/Accreditation in area of responsibility: Required Essential Functions: Serves as a senior member of the team, dedicated to the design, build and testing of electronic documentation solutions that support clinical and revenue cycle workflow. Leads project meetings and works cooperatively with team members to assign duties with the overall program and related projects with minimal managerial oversight. Facilitates application workflow design and application integration sessions. Designs, configures, tests, debugs, documents, and maintains programs/applications. Collaborates, researches, and analyzes to develop, configure, and modify moderately complex information systems based on or related to user system design specifications while utilizing established standards and departmental protocols. Designs and develops test scripts and materials for end-to-end workflow testing. Performs unit, system and integration testing per standards, documents outcomes. Evaluates user requests for special enhancements to systems. Collaborates with technical teams to define hardware/network requirements and to research and problem-solve technical issues. Installs and tests software per release checklist guidelines. Manages the planning and installation of automated systems. Works with end-users to develop specifications for the purchase, development and installation of software systems. Monitors progress of the plan and proposes corrective action where indicated. Utilizes appropriate planned change management models, principles and techniques in system planning, development, implementation and evaluation. Designs, develops, and monitors measurements of process improvements, including those enabled by standardized workflows. Provides ongoing support for existing computer applications. Provides support for problem resolution; escalates the problem to senior level personnel if necessary. Implements solutions, communicates to end users and tracks resolution. Analyzes incidents, identifying trends and major issues. Conducts routine status meetings with end users and leadership. Provides leadership support to analysts and team and to end-users regarding system applications. Maintains service level agreements with various end-user departments and enterprise business units. Supports the preparation and delivery of training materials and formal/informal training. Identifies educational opportunities related to standard applications and operational use of them. Develops strategies to educate analysts and support staff with focus to achieve improved operational understanding and efficiency. Leads various user group meetings as assigned. Mentors support groups to assist with their understanding of applications and processes. Handles ongoing on call duties for one or more applications which generate Incidents outside of business hours. Provides on call support as needed of the most critical applications. Troubleshoots and resolves system issues escalated by the help desk. As needed, up to 25%, travel on site to provide support during go-live events and other work-related occasions. Travel could occur during standard off-hours support times. Performs other job-related duties as assigned. Organizational Requirements: Adventist Health is committed to the safety and wellbeing of our associates and patients. Therefore, we require that all associates receive all required vaccinations as a condition of employment and annually thereafter, where applicable. Medical and religious exemptions may apply. Adventist Health participates in E-Verify. Visit for more information about E-Verify. By choosing to apply, you acknowledge that you have accessed and read the E-Verify Participation and Right to Work notices and understand the contents therein. ABOUT US Adventist Health is a faith-based, nonprofit, integrated health system serving more than 100 communities on the West Coast and Hawaii with over 440 sites of care, including 27 acute care facilities. Founded on Adventist heritage and values, Adventist Health provides care in hospitals, clinics, home care, and hospice agencies in both rural and urban communities. Our compassionate and talented team of more than 38,000 includes employees, physicians, Medical Staff, and volunteers driven in pursuit of one mission: living God's love by inspiring health, wholeness and hope.
09/25/2026
Full time
JOB DESCRIPTION Located in the metropolitan area of Sacramento, the Adventist Health corporate headquarters have been based in Roseville, California, for more than 40 years. In 2019, we unveiled our WELL-certified campus - a rejuvenating place for associates systemwide to collaborate, innovate and connect. Adventist Health Roseville and shared service teams have access to enjoy a welcoming space designed to promote well-being and inspire your best work. Job Summary: Adventist Health Roseville is seeking an Epic-Certified EHR Systems Analyst III for a full-time, day-shift position. We are looking for a strong candidate who can work primarily remotely, with the ability to travel up to 25% as required by the role. Candidates must have at least five (5) years of recent Epic Ambulatory experience. EpicCare Ambulatory certification is highly desirable , with a strong preference for candidates certified in Bones or Wisdom . Experience supporting Occupational Health or Occupational Medicine workflows in Epic is strongly preferred, including any exposure to the Epic Occupational Medicine (Occ Med) module . Leads the implementation and support of hospital information systems. Leads the planning, design, implementation, and maintenance of the existing systems and has a working knowledge of the applications for support and troubleshooting. Liaises between technical support, customers, and project teams in the design, implementation, and training of our healthcare information systems and any new enhanced systems. Utilizes comprehensive knowledge of Epic EHR system capabilities and functional use. Develops, recommends, and oversees implementation of policies and procedures for areas of responsibility. Job Requirements: Education and Work Experience: Bachelor's Degree or equivalent combination of education/related experience: Required Five years' healthcare IT application/technical experience: Required Five years' of applicable Epic application experience: Required Licenses/Certifications: Epic Certification/Accreditation in area of responsibility: Required Essential Functions: Serves as a senior member of the team, dedicated to the design, build and testing of electronic documentation solutions that support clinical and revenue cycle workflow. Leads project meetings and works cooperatively with team members to assign duties with the overall program and related projects with minimal managerial oversight. Facilitates application workflow design and application integration sessions. Designs, configures, tests, debugs, documents, and maintains programs/applications. Collaborates, researches, and analyzes to develop, configure, and modify moderately complex information systems based on or related to user system design specifications while utilizing established standards and departmental protocols. Designs and develops test scripts and materials for end-to-end workflow testing. Performs unit, system and integration testing per standards, documents outcomes. Evaluates user requests for special enhancements to systems. Collaborates with technical teams to define hardware/network requirements and to research and problem-solve technical issues. Installs and tests software per release checklist guidelines. Manages the planning and installation of automated systems. Works with end-users to develop specifications for the purchase, development and installation of software systems. Monitors progress of the plan and proposes corrective action where indicated. Utilizes appropriate planned change management models, principles and techniques in system planning, development, implementation and evaluation. Designs, develops, and monitors measurements of process improvements, including those enabled by standardized workflows. Provides ongoing support for existing computer applications. Provides support for problem resolution; escalates the problem to senior level personnel if necessary. Implements solutions, communicates to end users and tracks resolution. Analyzes incidents, identifying trends and major issues. Conducts routine status meetings with end users and leadership. Provides leadership support to analysts and team and to end-users regarding system applications. Maintains service level agreements with various end-user departments and enterprise business units. Supports the preparation and delivery of training materials and formal/informal training. Identifies educational opportunities related to standard applications and operational use of them. Develops strategies to educate analysts and support staff with focus to achieve improved operational understanding and efficiency. Leads various user group meetings as assigned. Mentors support groups to assist with their understanding of applications and processes. Handles ongoing on call duties for one or more applications which generate Incidents outside of business hours. Provides on call support as needed of the most critical applications. Troubleshoots and resolves system issues escalated by the help desk. As needed, up to 25%, travel on site to provide support during go-live events and other work-related occasions. Travel could occur during standard off-hours support times. Performs other job-related duties as assigned. Organizational Requirements: Adventist Health is committed to the safety and wellbeing of our associates and patients. Therefore, we require that all associates receive all required vaccinations as a condition of employment and annually thereafter, where applicable. Medical and religious exemptions may apply. Adventist Health participates in E-Verify. Visit for more information about E-Verify. By choosing to apply, you acknowledge that you have accessed and read the E-Verify Participation and Right to Work notices and understand the contents therein. ABOUT US Adventist Health is a faith-based, nonprofit, integrated health system serving more than 100 communities on the West Coast and Hawaii with over 440 sites of care, including 27 acute care facilities. Founded on Adventist heritage and values, Adventist Health provides care in hospitals, clinics, home care, and hospice agencies in both rural and urban communities. Our compassionate and talented team of more than 38,000 includes employees, physicians, Medical Staff, and volunteers driven in pursuit of one mission: living God's love by inspiring health, wholeness and hope.
JOB DESCRIPTION Located in the metropolitan area of Sacramento, the Adventist Health corporate headquarters have been based in Roseville, California, for more than 40 years. In 2019, we unveiled our WELL-certified campus - a rejuvenating place for associates systemwide to collaborate, innovate and connect. Adventist Health Roseville and shared service teams have access to enjoy a welcoming space designed to promote well-being and inspire your best work. Job Summary: Adventist Health Roseville is seeking an Epic-Certified EHR Systems Analyst III for a full-time, day-shift position. We are looking for a strong candidate who can work primarily remotely, with the ability to travel up to 25% as required by the role. Candidates must have at least five (5) years of recent Epic Ambulatory experience. EpicCare Ambulatory certification is highly desirable , with a strong preference for candidates certified in Bones or Wisdom . Experience supporting Occupational Health or Occupational Medicine workflows in Epic is strongly preferred, including any exposure to the Epic Occupational Medicine (Occ Med) module . Leads the implementation and support of hospital information systems. Leads the planning, design, implementation, and maintenance of the existing systems and has a working knowledge of the applications for support and troubleshooting. Liaises between technical support, customers, and project teams in the design, implementation, and training of our healthcare information systems and any new enhanced systems. Utilizes comprehensive knowledge of Epic EHR system capabilities and functional use. Develops, recommends, and oversees implementation of policies and procedures for areas of responsibility. Job Requirements: Education and Work Experience: Bachelor's Degree or equivalent combination of education/related experience: Required Five years' healthcare IT application/technical experience: Required Five years' of applicable Epic application experience: Required Licenses/Certifications: Epic Certification/Accreditation in area of responsibility: Required Essential Functions: Serves as a senior member of the team, dedicated to the design, build and testing of electronic documentation solutions that support clinical and revenue cycle workflow. Leads project meetings and works cooperatively with team members to assign duties with the overall program and related projects with minimal managerial oversight. Facilitates application workflow design and application integration sessions. Designs, configures, tests, debugs, documents, and maintains programs/applications. Collaborates, researches, and analyzes to develop, configure, and modify moderately complex information systems based on or related to user system design specifications while utilizing established standards and departmental protocols. Designs and develops test scripts and materials for end-to-end workflow testing. Performs unit, system and integration testing per standards, documents outcomes. Evaluates user requests for special enhancements to systems. Collaborates with technical teams to define hardware/network requirements and to research and problem-solve technical issues. Installs and tests software per release checklist guidelines. Manages the planning and installation of automated systems. Works with end-users to develop specifications for the purchase, development and installation of software systems. Monitors progress of the plan and proposes corrective action where indicated. Utilizes appropriate planned change management models, principles and techniques in system planning, development, implementation and evaluation. Designs, develops, and monitors measurements of process improvements, including those enabled by standardized workflows. Provides ongoing support for existing computer applications. Provides support for problem resolution; escalates the problem to senior level personnel if necessary. Implements solutions, communicates to end users and tracks resolution. Analyzes incidents, identifying trends and major issues. Conducts routine status meetings with end users and leadership. Provides leadership support to analysts and team and to end-users regarding system applications. Maintains service level agreements with various end-user departments and enterprise business units. Supports the preparation and delivery of training materials and formal/informal training. Identifies educational opportunities related to standard applications and operational use of them. Develops strategies to educate analysts and support staff with focus to achieve improved operational understanding and efficiency. Leads various user group meetings as assigned. Mentors support groups to assist with their understanding of applications and processes. Handles ongoing on call duties for one or more applications which generate Incidents outside of business hours. Provides on call support as needed of the most critical applications. Troubleshoots and resolves system issues escalated by the help desk. As needed, up to 25%, travel on site to provide support during go-live events and other work-related occasions. Travel could occur during standard off-hours support times. Performs other job-related duties as assigned. Organizational Requirements: Adventist Health is committed to the safety and wellbeing of our associates and patients. Therefore, we require that all associates receive all required vaccinations as a condition of employment and annually thereafter, where applicable. Medical and religious exemptions may apply. Adventist Health participates in E-Verify. Visit for more information about E-Verify. By choosing to apply, you acknowledge that you have accessed and read the E-Verify Participation and Right to Work notices and understand the contents therein. ABOUT US Adventist Health is a faith-based, nonprofit, integrated health system serving more than 100 communities on the West Coast and Hawaii with over 440 sites of care, including 27 acute care facilities. Founded on Adventist heritage and values, Adventist Health provides care in hospitals, clinics, home care, and hospice agencies in both rural and urban communities. Our compassionate and talented team of more than 38,000 includes employees, physicians, Medical Staff, and volunteers driven in pursuit of one mission: living God's love by inspiring health, wholeness and hope.
09/25/2026
Full time
JOB DESCRIPTION Located in the metropolitan area of Sacramento, the Adventist Health corporate headquarters have been based in Roseville, California, for more than 40 years. In 2019, we unveiled our WELL-certified campus - a rejuvenating place for associates systemwide to collaborate, innovate and connect. Adventist Health Roseville and shared service teams have access to enjoy a welcoming space designed to promote well-being and inspire your best work. Job Summary: Adventist Health Roseville is seeking an Epic-Certified EHR Systems Analyst III for a full-time, day-shift position. We are looking for a strong candidate who can work primarily remotely, with the ability to travel up to 25% as required by the role. Candidates must have at least five (5) years of recent Epic Ambulatory experience. EpicCare Ambulatory certification is highly desirable , with a strong preference for candidates certified in Bones or Wisdom . Experience supporting Occupational Health or Occupational Medicine workflows in Epic is strongly preferred, including any exposure to the Epic Occupational Medicine (Occ Med) module . Leads the implementation and support of hospital information systems. Leads the planning, design, implementation, and maintenance of the existing systems and has a working knowledge of the applications for support and troubleshooting. Liaises between technical support, customers, and project teams in the design, implementation, and training of our healthcare information systems and any new enhanced systems. Utilizes comprehensive knowledge of Epic EHR system capabilities and functional use. Develops, recommends, and oversees implementation of policies and procedures for areas of responsibility. Job Requirements: Education and Work Experience: Bachelor's Degree or equivalent combination of education/related experience: Required Five years' healthcare IT application/technical experience: Required Five years' of applicable Epic application experience: Required Licenses/Certifications: Epic Certification/Accreditation in area of responsibility: Required Essential Functions: Serves as a senior member of the team, dedicated to the design, build and testing of electronic documentation solutions that support clinical and revenue cycle workflow. Leads project meetings and works cooperatively with team members to assign duties with the overall program and related projects with minimal managerial oversight. Facilitates application workflow design and application integration sessions. Designs, configures, tests, debugs, documents, and maintains programs/applications. Collaborates, researches, and analyzes to develop, configure, and modify moderately complex information systems based on or related to user system design specifications while utilizing established standards and departmental protocols. Designs and develops test scripts and materials for end-to-end workflow testing. Performs unit, system and integration testing per standards, documents outcomes. Evaluates user requests for special enhancements to systems. Collaborates with technical teams to define hardware/network requirements and to research and problem-solve technical issues. Installs and tests software per release checklist guidelines. Manages the planning and installation of automated systems. Works with end-users to develop specifications for the purchase, development and installation of software systems. Monitors progress of the plan and proposes corrective action where indicated. Utilizes appropriate planned change management models, principles and techniques in system planning, development, implementation and evaluation. Designs, develops, and monitors measurements of process improvements, including those enabled by standardized workflows. Provides ongoing support for existing computer applications. Provides support for problem resolution; escalates the problem to senior level personnel if necessary. Implements solutions, communicates to end users and tracks resolution. Analyzes incidents, identifying trends and major issues. Conducts routine status meetings with end users and leadership. Provides leadership support to analysts and team and to end-users regarding system applications. Maintains service level agreements with various end-user departments and enterprise business units. Supports the preparation and delivery of training materials and formal/informal training. Identifies educational opportunities related to standard applications and operational use of them. Develops strategies to educate analysts and support staff with focus to achieve improved operational understanding and efficiency. Leads various user group meetings as assigned. Mentors support groups to assist with their understanding of applications and processes. Handles ongoing on call duties for one or more applications which generate Incidents outside of business hours. Provides on call support as needed of the most critical applications. Troubleshoots and resolves system issues escalated by the help desk. As needed, up to 25%, travel on site to provide support during go-live events and other work-related occasions. Travel could occur during standard off-hours support times. Performs other job-related duties as assigned. Organizational Requirements: Adventist Health is committed to the safety and wellbeing of our associates and patients. Therefore, we require that all associates receive all required vaccinations as a condition of employment and annually thereafter, where applicable. Medical and religious exemptions may apply. Adventist Health participates in E-Verify. Visit for more information about E-Verify. By choosing to apply, you acknowledge that you have accessed and read the E-Verify Participation and Right to Work notices and understand the contents therein. ABOUT US Adventist Health is a faith-based, nonprofit, integrated health system serving more than 100 communities on the West Coast and Hawaii with over 440 sites of care, including 27 acute care facilities. Founded on Adventist heritage and values, Adventist Health provides care in hospitals, clinics, home care, and hospice agencies in both rural and urban communities. Our compassionate and talented team of more than 38,000 includes employees, physicians, Medical Staff, and volunteers driven in pursuit of one mission: living God's love by inspiring health, wholeness and hope.
Job DescriptionJob Description Overview Advanced Battle Management System Test Manager LOCATION: Eglin AFB, FL Salary Range: If required JOB STATUS: Full-time CLEARANCE: Secret TRAVEL: 25% Astrion has an exciting opportunity for a senior level Advanced Battle Management System Test Manger located at Eglin AFB, Florida. REQUIRED QUALIFICATIONS / SKILLS Master's Degree in a technical field and 10 years of relevant experience. Additional experience may be substituted for education. An Active Secret Clearance with the ability to obtain and maintain a Top Secret clearance. U.S. Citizenship is required. Prior work experience in Developmental Test and Evaluation (DT&E). Experience writing, reviewing or editing Test and Evaluation Master Plan (TEMP), Test and Evaluation Strategy (TES), Test Plan and Test Report documentation. Experience with the Deficiency Reporting (DR) process for agile or DevSecOps software development programs. Advanced proficiency in Office 365 products to include Word, Excel PowerPoint, Teams and Sharepoint. Experience interfacing with multiple stakeholders regarding project scope, status, schedules, and required documentation. Effective oral and written communications skills, good interpersonal communications skills and comfortable working in a team environment. High level of self-initiative and self-motivation with the ability to work under minimal supervision. Must be capable of traveling to TDY locations as needed. PREFERRED QUALIFICATIONS / SKILLS Experience working in a highly technical environment or with advanced technology test programs. Familiarity with Information Technology infrastructure, networking, cybersecurity and software development practices. Familiarity with Agile Development processes and DevSecOps. Proficient using Confluence and JIRA workspaces and collaboration tools. In-depth knowledge of DODI 5000.89/DAFI 99-103, Capabilities-Based Test and Evaluation. In depth knowledge of the Middle Tier and Software acquisition pathways Have in-depth knowledge of battle management processes and systems at multiple security levels to better understand how to develop test plans and lead a complex test of multiple systems for collection and analysis of valid and accurate data. Active Top Secret clearance. RESPONSIBILITIES Manage test schedule and documentation for complex C2 system of systems test projects from initiation to completion. Manage information systems for team collaboration, document management and meeting schedules. Provide detailed analysis of courses of action (COAs) for test projects, analyze and make recommendations for improvements and optimization of test projects to ABMS Test leadership. Write, edit, and maintain technical test documentation and track test program status. Organize and interpret data to inform DOD decision makers, turn data into actionable knowledge; drive successful operations and shape organization technology and resource investments. Support test engineers when interacting with System Program Offices, other military services, and development contractors.
09/25/2026
Full time
Job DescriptionJob Description Overview Advanced Battle Management System Test Manager LOCATION: Eglin AFB, FL Salary Range: If required JOB STATUS: Full-time CLEARANCE: Secret TRAVEL: 25% Astrion has an exciting opportunity for a senior level Advanced Battle Management System Test Manger located at Eglin AFB, Florida. REQUIRED QUALIFICATIONS / SKILLS Master's Degree in a technical field and 10 years of relevant experience. Additional experience may be substituted for education. An Active Secret Clearance with the ability to obtain and maintain a Top Secret clearance. U.S. Citizenship is required. Prior work experience in Developmental Test and Evaluation (DT&E). Experience writing, reviewing or editing Test and Evaluation Master Plan (TEMP), Test and Evaluation Strategy (TES), Test Plan and Test Report documentation. Experience with the Deficiency Reporting (DR) process for agile or DevSecOps software development programs. Advanced proficiency in Office 365 products to include Word, Excel PowerPoint, Teams and Sharepoint. Experience interfacing with multiple stakeholders regarding project scope, status, schedules, and required documentation. Effective oral and written communications skills, good interpersonal communications skills and comfortable working in a team environment. High level of self-initiative and self-motivation with the ability to work under minimal supervision. Must be capable of traveling to TDY locations as needed. PREFERRED QUALIFICATIONS / SKILLS Experience working in a highly technical environment or with advanced technology test programs. Familiarity with Information Technology infrastructure, networking, cybersecurity and software development practices. Familiarity with Agile Development processes and DevSecOps. Proficient using Confluence and JIRA workspaces and collaboration tools. In-depth knowledge of DODI 5000.89/DAFI 99-103, Capabilities-Based Test and Evaluation. In depth knowledge of the Middle Tier and Software acquisition pathways Have in-depth knowledge of battle management processes and systems at multiple security levels to better understand how to develop test plans and lead a complex test of multiple systems for collection and analysis of valid and accurate data. Active Top Secret clearance. RESPONSIBILITIES Manage test schedule and documentation for complex C2 system of systems test projects from initiation to completion. Manage information systems for team collaboration, document management and meeting schedules. Provide detailed analysis of courses of action (COAs) for test projects, analyze and make recommendations for improvements and optimization of test projects to ABMS Test leadership. Write, edit, and maintain technical test documentation and track test program status. Organize and interpret data to inform DOD decision makers, turn data into actionable knowledge; drive successful operations and shape organization technology and resource investments. Support test engineers when interacting with System Program Offices, other military services, and development contractors.
Job DescriptionJob Description Active Top Secret and DHS Suitability Required About Aretum Aretum is a mission-driven organization committed to delivering innovative, technology-enabled solutions to our customers across defense, civilian, and homeland security sectors. Our teams work at the intersection of strategy, technology, and transformation, helping agencies solve their most critical challenges. We believe in investing in our people and creating a culture where collaboration, inclusion, and professional growth are at the forefront. Job Summary Aretum is seeking a Facilitation Manager that integrates information sharing, analysis, and operational coordination across external partners and internal offices while supporting cybersecurity planning and strategic initiatives. Provide technical expertise in cyber threat intelligence, security operations, and cyber incident response, translating complex technical information for executive audiences through briefings and written products while leading staff and client relationships. Due to the nature of our work as a federal consulting organization, employees may be expected to handle Controlled Unclassified Information and must adhere to applicable safeguarding and compliance requirements. Responsibilities Coordinate information sharing, analysis, and operational activities across external cybersecurity partners and internal offices. Support cybersecurity planning and strategic initiatives by identifying trends, operational needs, and opportunities for improved coordination. Analyze cyber threat intelligence, security operations, and incident response information and translate technical findings into clear information for executive audiences. Develop and deliver executive briefings, written products, and other communications for senior leaders and stakeholders. Lead and manage staff while maintaining strong client relationships and coordinating work across assigned activities. Requirements BA/BS degree and 10-15 years of relevant experience, or an equivalent combination of education and experience. Experience with cyber threat intelligence, security operations, and cyber incident response. Strong ability to translate complex technical information into clear executive-level briefings and written products. Excellent communication, collaboration, and coordination skills, including experience working with cybersecurity industry partners. Experience working across both technical and policy environments to support cybersecurity operations and strategic initiatives. Demonstrated experience leading staff, managing client relationships, and coordinating similar cybersecurity workstreams. Travel Requirements This is a hybrid position, with work performed both remotely and at designated client or corporate locations, as needed. Travel requirements may vary depending on project assignments, client meetings, or internal collaboration and will be communicated in advance whenever possible. Benefits Salary Range: $170,000-$200,000 annually. Final compensation will be determined based on factors including education, experience, qualifications, skills, and applicable contract requirements. Health Care Plan (Medical, Dental & Vision) Retirement Plan (401k) Life Insurance (Basic, Voluntary & AD&D) Paid Time Off Family Leave (Maternity, Paternity) Short Term & Long-Term Disability Training & Development EEO Statement Aretum is committed to fostering a workplace rooted in excellence, integrity, and equal opportunity for all. We adhere to merit-based hiring practices, ensuring that all employment decisions are made based on qualifications, skills, and ability to perform the job, without preference or consideration of factors unrelated to job performance. As an Equal Opportunity Employer, Aretum complies with all applicable federal, state, and local employment laws. We are proud to support our nation's veterans and military families, providing career opportunities that honor their service and experience. If you require reasonable accommodation during the hiring process due to a disability, please contact for assistance. Equal Opportunity Employer/Veterans/Disabled
09/25/2026
Full time
Job DescriptionJob Description Active Top Secret and DHS Suitability Required About Aretum Aretum is a mission-driven organization committed to delivering innovative, technology-enabled solutions to our customers across defense, civilian, and homeland security sectors. Our teams work at the intersection of strategy, technology, and transformation, helping agencies solve their most critical challenges. We believe in investing in our people and creating a culture where collaboration, inclusion, and professional growth are at the forefront. Job Summary Aretum is seeking a Facilitation Manager that integrates information sharing, analysis, and operational coordination across external partners and internal offices while supporting cybersecurity planning and strategic initiatives. Provide technical expertise in cyber threat intelligence, security operations, and cyber incident response, translating complex technical information for executive audiences through briefings and written products while leading staff and client relationships. Due to the nature of our work as a federal consulting organization, employees may be expected to handle Controlled Unclassified Information and must adhere to applicable safeguarding and compliance requirements. Responsibilities Coordinate information sharing, analysis, and operational activities across external cybersecurity partners and internal offices. Support cybersecurity planning and strategic initiatives by identifying trends, operational needs, and opportunities for improved coordination. Analyze cyber threat intelligence, security operations, and incident response information and translate technical findings into clear information for executive audiences. Develop and deliver executive briefings, written products, and other communications for senior leaders and stakeholders. Lead and manage staff while maintaining strong client relationships and coordinating work across assigned activities. Requirements BA/BS degree and 10-15 years of relevant experience, or an equivalent combination of education and experience. Experience with cyber threat intelligence, security operations, and cyber incident response. Strong ability to translate complex technical information into clear executive-level briefings and written products. Excellent communication, collaboration, and coordination skills, including experience working with cybersecurity industry partners. Experience working across both technical and policy environments to support cybersecurity operations and strategic initiatives. Demonstrated experience leading staff, managing client relationships, and coordinating similar cybersecurity workstreams. Travel Requirements This is a hybrid position, with work performed both remotely and at designated client or corporate locations, as needed. Travel requirements may vary depending on project assignments, client meetings, or internal collaboration and will be communicated in advance whenever possible. Benefits Salary Range: $170,000-$200,000 annually. Final compensation will be determined based on factors including education, experience, qualifications, skills, and applicable contract requirements. Health Care Plan (Medical, Dental & Vision) Retirement Plan (401k) Life Insurance (Basic, Voluntary & AD&D) Paid Time Off Family Leave (Maternity, Paternity) Short Term & Long-Term Disability Training & Development EEO Statement Aretum is committed to fostering a workplace rooted in excellence, integrity, and equal opportunity for all. We adhere to merit-based hiring practices, ensuring that all employment decisions are made based on qualifications, skills, and ability to perform the job, without preference or consideration of factors unrelated to job performance. As an Equal Opportunity Employer, Aretum complies with all applicable federal, state, and local employment laws. We are proud to support our nation's veterans and military families, providing career opportunities that honor their service and experience. If you require reasonable accommodation during the hiring process due to a disability, please contact for assistance. Equal Opportunity Employer/Veterans/Disabled
Job DescriptionJob Description Overview Advanced Battle Management System Test Manager LOCATION: Eglin AFB, FL Salary Range: If required JOB STATUS: Full-time CLEARANCE: Secret TRAVEL: 25% Astrion has an exciting opportunity for a senior level Advanced Battle Management System Test Manger located at Eglin AFB, Florida. REQUIRED QUALIFICATIONS / SKILLS Master's Degree in a technical field and 10 years of relevant experience. Additional experience may be substituted for education. An Active Secret Clearance with the ability to obtain and maintain a Top Secret clearance. U.S. Citizenship is required. Prior work experience in Developmental Test and Evaluation (DT&E). Experience writing, reviewing or editing Test and Evaluation Master Plan (TEMP), Test and Evaluation Strategy (TES), Test Plan and Test Report documentation. Experience with the Deficiency Reporting (DR) process for agile or DevSecOps software development programs. Advanced proficiency in Office 365 products to include Word, Excel PowerPoint, Teams and Sharepoint. Experience interfacing with multiple stakeholders regarding project scope, status, schedules, and required documentation. Effective oral and written communications skills, good interpersonal communications skills and comfortable working in a team environment. High level of self-initiative and self-motivation with the ability to work under minimal supervision. Must be capable of traveling to TDY locations as needed. PREFERRED QUALIFICATIONS / SKILLS Experience working in a highly technical environment or with advanced technology test programs. Familiarity with Information Technology infrastructure, networking, cybersecurity and software development practices. Familiarity with Agile Development processes and DevSecOps. Proficient using Confluence and JIRA workspaces and collaboration tools. In-depth knowledge of DODI 5000.89/DAFI 99-103, Capabilities-Based Test and Evaluation. In depth knowledge of the Middle Tier and Software acquisition pathways Have in-depth knowledge of battle management processes and systems at multiple security levels to better understand how to develop test plans and lead a complex test of multiple systems for collection and analysis of valid and accurate data. Active Top Secret clearance. RESPONSIBILITIES Manage test schedule and documentation for complex C2 system of systems test projects from initiation to completion. Manage information systems for team collaboration, document management and meeting schedules. Provide detailed analysis of courses of action (COAs) for test projects, analyze and make recommendations for improvements and optimization of test projects to ABMS Test leadership. Write, edit, and maintain technical test documentation and track test program status. Organize and interpret data to inform DOD decision makers, turn data into actionable knowledge; drive successful operations and shape organization technology and resource investments. Support test engineers when interacting with System Program Offices, other military services, and development contractors.
09/25/2026
Full time
Job DescriptionJob Description Overview Advanced Battle Management System Test Manager LOCATION: Eglin AFB, FL Salary Range: If required JOB STATUS: Full-time CLEARANCE: Secret TRAVEL: 25% Astrion has an exciting opportunity for a senior level Advanced Battle Management System Test Manger located at Eglin AFB, Florida. REQUIRED QUALIFICATIONS / SKILLS Master's Degree in a technical field and 10 years of relevant experience. Additional experience may be substituted for education. An Active Secret Clearance with the ability to obtain and maintain a Top Secret clearance. U.S. Citizenship is required. Prior work experience in Developmental Test and Evaluation (DT&E). Experience writing, reviewing or editing Test and Evaluation Master Plan (TEMP), Test and Evaluation Strategy (TES), Test Plan and Test Report documentation. Experience with the Deficiency Reporting (DR) process for agile or DevSecOps software development programs. Advanced proficiency in Office 365 products to include Word, Excel PowerPoint, Teams and Sharepoint. Experience interfacing with multiple stakeholders regarding project scope, status, schedules, and required documentation. Effective oral and written communications skills, good interpersonal communications skills and comfortable working in a team environment. High level of self-initiative and self-motivation with the ability to work under minimal supervision. Must be capable of traveling to TDY locations as needed. PREFERRED QUALIFICATIONS / SKILLS Experience working in a highly technical environment or with advanced technology test programs. Familiarity with Information Technology infrastructure, networking, cybersecurity and software development practices. Familiarity with Agile Development processes and DevSecOps. Proficient using Confluence and JIRA workspaces and collaboration tools. In-depth knowledge of DODI 5000.89/DAFI 99-103, Capabilities-Based Test and Evaluation. In depth knowledge of the Middle Tier and Software acquisition pathways Have in-depth knowledge of battle management processes and systems at multiple security levels to better understand how to develop test plans and lead a complex test of multiple systems for collection and analysis of valid and accurate data. Active Top Secret clearance. RESPONSIBILITIES Manage test schedule and documentation for complex C2 system of systems test projects from initiation to completion. Manage information systems for team collaboration, document management and meeting schedules. Provide detailed analysis of courses of action (COAs) for test projects, analyze and make recommendations for improvements and optimization of test projects to ABMS Test leadership. Write, edit, and maintain technical test documentation and track test program status. Organize and interpret data to inform DOD decision makers, turn data into actionable knowledge; drive successful operations and shape organization technology and resource investments. Support test engineers when interacting with System Program Offices, other military services, and development contractors.
BlackTree Technical Group, Inc.
Billerica, Massachusetts
Job Description Job Description Test Executor - Contract Job Summary: The Test Executor will work as part of a multidisciplinary technical team to test, operate, set up testing infrastructure, and maintain complex robotic and electromechanical systems. This role will support day-to-day testing operations, primarily in an indoor environment. Responsibilities will include preparing systems for testing, operating cameras and other testing equipment, communicating system status to engineers and technicians, setting up testing environments, and supporting general test operations. This position includes a significant hands-on and physical component. Key Responsibilities: Perform software and hardware testing on robotic and electromechanical systems, documenting test results, findings, and issues. Collaborate with software quality, service, and engineering teams to troubleshoot and resolve hardware and software issues. Accurately complete test documentation and maintain detailed records in accordance with established procedures. Support demonstrations and presentations of systems for customers and visitors. Work with software, hardware, and systems engineering teams to improve testing processes and procedures. Track test activities, issues, and results using standard documentation and project management tools. Handle and stack boxes or equipment weighing up to 50 lbs. Required SkillsTechnical Skills: Technical knowledge and hands-on experience with electronics. Comfortable working with a variety of user interfaces, controllers, and technical equipment. Experience using common productivity, communication, and task-management software. Strong troubleshooting and problem-solving abilities. Ability to quickly learn new technical terminology, concepts, and procedures. Experience performing software and hardware testing. Ability to identify, document, and communicate defects, failures, and anomalies. Essential Skills: Strong verbal and written communication skills. Excellent organizational and documentation abilities. Ability to work independently with minimal supervision while collaborating effectively with a broader technical team. Strong attention to detail and commitment to accuracy. Strong customer-service orientation when supporting internal and external stakeholders. Adaptability and willingness to handle a variety of technical and administrative tasks. Comfortable working in a hands-on testing environment. Preferred Skills: Experience working with Linux or similar technical operating systems. Experience operating forklifts, scissor lifts, walkie stackers, or similar equipment. Previous experience testing finished products, identifying defects, and debugging failures or anomalies. Experience with graphics or design software and basic visual communication concepts. Experience working in manufacturing, robotics, or other technical production environments. Familiarity with manufacturing processes, quality control systems, or industry standards. Travel & Transportation: Reliable transportation is required. Occasional travel may be required, up to approximately 10%. Company Description BlackTree Technical Group is a full-service staffing and recruitment firm. Our team consists of an experienced group of Senior Technical Recruiters and Account Managers with over 40 years of industry experience. Our firm prides itself on our technical knowledge, innovative sourcing strategies, and most importantly, a long-standing record of proven results for both clients and job-seekers. Company Description BlackTree Technical Group is a full-service staffing and recruitment firm. Our team consists of an experienced group of Senior Technical Recruiters and Account Managers with over 40 years of industry experience. Our firm prides itself on our technical knowledge, innovative sourcing strategies, and most importantly, a long-standing record of proven results for both clients and job-seekers.
09/25/2026
Full time
Job Description Job Description Test Executor - Contract Job Summary: The Test Executor will work as part of a multidisciplinary technical team to test, operate, set up testing infrastructure, and maintain complex robotic and electromechanical systems. This role will support day-to-day testing operations, primarily in an indoor environment. Responsibilities will include preparing systems for testing, operating cameras and other testing equipment, communicating system status to engineers and technicians, setting up testing environments, and supporting general test operations. This position includes a significant hands-on and physical component. Key Responsibilities: Perform software and hardware testing on robotic and electromechanical systems, documenting test results, findings, and issues. Collaborate with software quality, service, and engineering teams to troubleshoot and resolve hardware and software issues. Accurately complete test documentation and maintain detailed records in accordance with established procedures. Support demonstrations and presentations of systems for customers and visitors. Work with software, hardware, and systems engineering teams to improve testing processes and procedures. Track test activities, issues, and results using standard documentation and project management tools. Handle and stack boxes or equipment weighing up to 50 lbs. Required SkillsTechnical Skills: Technical knowledge and hands-on experience with electronics. Comfortable working with a variety of user interfaces, controllers, and technical equipment. Experience using common productivity, communication, and task-management software. Strong troubleshooting and problem-solving abilities. Ability to quickly learn new technical terminology, concepts, and procedures. Experience performing software and hardware testing. Ability to identify, document, and communicate defects, failures, and anomalies. Essential Skills: Strong verbal and written communication skills. Excellent organizational and documentation abilities. Ability to work independently with minimal supervision while collaborating effectively with a broader technical team. Strong attention to detail and commitment to accuracy. Strong customer-service orientation when supporting internal and external stakeholders. Adaptability and willingness to handle a variety of technical and administrative tasks. Comfortable working in a hands-on testing environment. Preferred Skills: Experience working with Linux or similar technical operating systems. Experience operating forklifts, scissor lifts, walkie stackers, or similar equipment. Previous experience testing finished products, identifying defects, and debugging failures or anomalies. Experience with graphics or design software and basic visual communication concepts. Experience working in manufacturing, robotics, or other technical production environments. Familiarity with manufacturing processes, quality control systems, or industry standards. Travel & Transportation: Reliable transportation is required. Occasional travel may be required, up to approximately 10%. Company Description BlackTree Technical Group is a full-service staffing and recruitment firm. Our team consists of an experienced group of Senior Technical Recruiters and Account Managers with over 40 years of industry experience. Our firm prides itself on our technical knowledge, innovative sourcing strategies, and most importantly, a long-standing record of proven results for both clients and job-seekers. Company Description BlackTree Technical Group is a full-service staffing and recruitment firm. Our team consists of an experienced group of Senior Technical Recruiters and Account Managers with over 40 years of industry experience. Our firm prides itself on our technical knowledge, innovative sourcing strategies, and most importantly, a long-standing record of proven results for both clients and job-seekers.
About Us Visa is a world leader in payments technology, facilitating transactions between consumers, merchants, financial institutions and government entities across more than 200 countries and territories, dedicated to uplifting everyone, everywhere by being the best way to pay and be paid. At Visa, you'll have the opportunity to create impact at scale - tackling meaningful challenges, growing your skills and seeing your contributions impact lives around the world. Join Visa and do work that matters - to you, to your community, and to the world. Progress starts with you. Job Description Visa's Technology Organization is a community of problem solvers and innovators reshaping the future of commerce. We operate the world's most sophisticated processing networks capable of handling more than 65k secure transactions a second across 80M merchants, 15k Financial Institutions, and billions of everyday people. While working with us you'll get to work on complex distributed systems and solve massive scale problems centered on new payment flows, business and data solutions, cyber security, and B2C platforms. The Opportunity: We are looking for Versatile, curious, and energetic Software Engineers who embrace solving complex challenges on a global scale. As a Visa Software Engineer, you will be an integral part of a multi-functional development team inventing, designing, building, and testing software products that reach a truly global customer base. Join the Commercial and Money Movement Solutions (CMS) organization as a Senior Staff Engineer focused on leveraging AI to solve complex engineering and customer challenges. You will work on innovative solutions that combine deep technical expertise with AI/ML capabilities to enhance developer productivity, improve customer experiences, and drive next-generation commercial payment and money movement technology for B2B, B2C, P2P, and G2C flows. The Work itself: Design and architect AI-powered solutions that solve engineering productivity challenges and enhance customer-facing products across CMS Lead technical initiatives leveraging agentic AI, LLMs, and machine learning to automate workflows and improve software quality Collaborate multi-functionally to create design artifacts and develop best-in-class software solutions for multiple Visa technical offerings Drive experimentation with emerging AI technologies and make technical decisions on adoption and standards Develop robust and scalable products intended for a myriad of customers including end-user merchants, b2b, and business to government solutions. Develop scalable platforms and services that integrate AI capabilities into Visa's commercial payment and money movement systems Opportunities to make a difference on a global or local scale through mentorship and continued learning opportunities Essential Functions: Works directly with product owners to gather and refine requirements across products, adding and taking into account existing tools and solutions across the organization. Develops and designs advanced architect solutions that are robust and scalable, integrating AI capabilities with Visa's technical ecosystem Provides domain expertise on the development of technical documentation of solutions and contributes to standard processes in technical documentation as needed. Plays a key role in the development and delivery of new features across products from end-to-end. This is a hybrid position. Expectation of days in the office will be confirmed by your Hiring Manager. Visa requires at least 3 days in office, expectations of these days will be confirmed by your Hiring Manager. Qualifications Basic Qualifications • 8+ years of relevant work experience with a Bachelor's Degree or at least 5 years of experience with an Advanced Degree (e.g. Masters, MBA, JD, MD) or 2 years of work experience with a PhD, OR 11+ years of relevant work experience. Preferred Qualifications • 9 or more years of relevant work experience with a Bachelor Degree or 7 or more relevant years of experience with an Advanced Degree (e.g. Masters, MBA, JD, MD) or 3 or more years of experience with a PhD • Master's degree in Math, Science, Engineering, Computer Science, Information Systems or related field AND minimum six (6) years of experience in a directly related field OR Bachelor's degree in Math, Science, Engineering, Computer Science, Information Systems or related field AND minimum eight (8) years of experience in a directly related field OR Minimum eleven (11) years of directly related experience • Experience with AI agent frameworks, LLMs, or generative AI applications (Claude, GPT, etc.) • Knowledge of AI-powered development tools (Claude Code, GitHub Copilot, etc.) or building similar systems • Experience applying AI to solve engineering challenges or customer-facing product features • Understanding of commercial payments, money movement, B2B payables, or payment processing • Experience with cloud platforms (AWS, Azure, GCP) and modern architectures • Knowledge of API design, microservices, and distributed systems • Experience leading cross-team technical initiatives The Skills You Bring • Energy and Experience: A growth mindset that is curious and passionate about technologies and enjoys challenging projects on a global scale • AI Expertise: Experience with agentic AI, LLMs, AI agent frameworks, or machine learning applications • Challenge the Status Quo: Comfort in pushing the boundaries, 'hacking' beyond traditional solutions • Language Expertise: Expertise in one or more general development languages (e.g., Java, C#, C++) • Architecture & Design: Proven track record designing scalable systems that integrate AI capabilities • Builder: Experience building AI-powered features for engineering productivity or customer-facing applications • Learner: Constant drive to learn new technologies such as Angular, React, Kubernetes, Docker, etc. • Partnership: Experience collaborating with Product, Test, Dev-ops, and Agile/Scrum teams • We do not expect that any single candidate would fulfill all of these characteristics. For instance, we have exciting team members who are really focused on building scalable systems but didn't work with payments technology or web applications before joining Visa. Information for US Applicants For roles located in the US, the estimated salary range for this position is $169,100.00 to $ 270,800.00 USD per year, which may include potential sales incentive payments (if applicable). Salary may vary depending on job-related factors which may include knowledge, skills, experience, and location. In addition, this position may be eligible for bonus and equity.Visa has a comprehensive benefits package for which this position may be eligible that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness Program. Work Hours Varies upon the needs of the department. Travel Requirements This position requires travel 5-10% of the time. Mental/Physical Requirements This position will be performed in an office setting. The position will require the incumbent to sit and stand at a desk, communicate in person and by telephone, frequently operate standard office equipment, such as telephones and computers. Visa is an EEO Employer Qualified applicants will receive consideration for employment without regard to race, color religion, sex, national origin, sexual orientation, gender identity, disability or protect veteran status. Visa will also consider for employment qualified applicants with criminal histories in a manner consistent with the EEOC guidelines and applicable local law.
09/25/2026
Full time
About Us Visa is a world leader in payments technology, facilitating transactions between consumers, merchants, financial institutions and government entities across more than 200 countries and territories, dedicated to uplifting everyone, everywhere by being the best way to pay and be paid. At Visa, you'll have the opportunity to create impact at scale - tackling meaningful challenges, growing your skills and seeing your contributions impact lives around the world. Join Visa and do work that matters - to you, to your community, and to the world. Progress starts with you. Job Description Visa's Technology Organization is a community of problem solvers and innovators reshaping the future of commerce. We operate the world's most sophisticated processing networks capable of handling more than 65k secure transactions a second across 80M merchants, 15k Financial Institutions, and billions of everyday people. While working with us you'll get to work on complex distributed systems and solve massive scale problems centered on new payment flows, business and data solutions, cyber security, and B2C platforms. The Opportunity: We are looking for Versatile, curious, and energetic Software Engineers who embrace solving complex challenges on a global scale. As a Visa Software Engineer, you will be an integral part of a multi-functional development team inventing, designing, building, and testing software products that reach a truly global customer base. Join the Commercial and Money Movement Solutions (CMS) organization as a Senior Staff Engineer focused on leveraging AI to solve complex engineering and customer challenges. You will work on innovative solutions that combine deep technical expertise with AI/ML capabilities to enhance developer productivity, improve customer experiences, and drive next-generation commercial payment and money movement technology for B2B, B2C, P2P, and G2C flows. The Work itself: Design and architect AI-powered solutions that solve engineering productivity challenges and enhance customer-facing products across CMS Lead technical initiatives leveraging agentic AI, LLMs, and machine learning to automate workflows and improve software quality Collaborate multi-functionally to create design artifacts and develop best-in-class software solutions for multiple Visa technical offerings Drive experimentation with emerging AI technologies and make technical decisions on adoption and standards Develop robust and scalable products intended for a myriad of customers including end-user merchants, b2b, and business to government solutions. Develop scalable platforms and services that integrate AI capabilities into Visa's commercial payment and money movement systems Opportunities to make a difference on a global or local scale through mentorship and continued learning opportunities Essential Functions: Works directly with product owners to gather and refine requirements across products, adding and taking into account existing tools and solutions across the organization. Develops and designs advanced architect solutions that are robust and scalable, integrating AI capabilities with Visa's technical ecosystem Provides domain expertise on the development of technical documentation of solutions and contributes to standard processes in technical documentation as needed. Plays a key role in the development and delivery of new features across products from end-to-end. This is a hybrid position. Expectation of days in the office will be confirmed by your Hiring Manager. Visa requires at least 3 days in office, expectations of these days will be confirmed by your Hiring Manager. Qualifications Basic Qualifications • 8+ years of relevant work experience with a Bachelor's Degree or at least 5 years of experience with an Advanced Degree (e.g. Masters, MBA, JD, MD) or 2 years of work experience with a PhD, OR 11+ years of relevant work experience. Preferred Qualifications • 9 or more years of relevant work experience with a Bachelor Degree or 7 or more relevant years of experience with an Advanced Degree (e.g. Masters, MBA, JD, MD) or 3 or more years of experience with a PhD • Master's degree in Math, Science, Engineering, Computer Science, Information Systems or related field AND minimum six (6) years of experience in a directly related field OR Bachelor's degree in Math, Science, Engineering, Computer Science, Information Systems or related field AND minimum eight (8) years of experience in a directly related field OR Minimum eleven (11) years of directly related experience • Experience with AI agent frameworks, LLMs, or generative AI applications (Claude, GPT, etc.) • Knowledge of AI-powered development tools (Claude Code, GitHub Copilot, etc.) or building similar systems • Experience applying AI to solve engineering challenges or customer-facing product features • Understanding of commercial payments, money movement, B2B payables, or payment processing • Experience with cloud platforms (AWS, Azure, GCP) and modern architectures • Knowledge of API design, microservices, and distributed systems • Experience leading cross-team technical initiatives The Skills You Bring • Energy and Experience: A growth mindset that is curious and passionate about technologies and enjoys challenging projects on a global scale • AI Expertise: Experience with agentic AI, LLMs, AI agent frameworks, or machine learning applications • Challenge the Status Quo: Comfort in pushing the boundaries, 'hacking' beyond traditional solutions • Language Expertise: Expertise in one or more general development languages (e.g., Java, C#, C++) • Architecture & Design: Proven track record designing scalable systems that integrate AI capabilities • Builder: Experience building AI-powered features for engineering productivity or customer-facing applications • Learner: Constant drive to learn new technologies such as Angular, React, Kubernetes, Docker, etc. • Partnership: Experience collaborating with Product, Test, Dev-ops, and Agile/Scrum teams • We do not expect that any single candidate would fulfill all of these characteristics. For instance, we have exciting team members who are really focused on building scalable systems but didn't work with payments technology or web applications before joining Visa. Information for US Applicants For roles located in the US, the estimated salary range for this position is $169,100.00 to $ 270,800.00 USD per year, which may include potential sales incentive payments (if applicable). Salary may vary depending on job-related factors which may include knowledge, skills, experience, and location. In addition, this position may be eligible for bonus and equity.Visa has a comprehensive benefits package for which this position may be eligible that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness Program. Work Hours Varies upon the needs of the department. Travel Requirements This position requires travel 5-10% of the time. Mental/Physical Requirements This position will be performed in an office setting. The position will require the incumbent to sit and stand at a desk, communicate in person and by telephone, frequently operate standard office equipment, such as telephones and computers. Visa is an EEO Employer Qualified applicants will receive consideration for employment without regard to race, color religion, sex, national origin, sexual orientation, gender identity, disability or protect veteran status. Visa will also consider for employment qualified applicants with criminal histories in a manner consistent with the EEOC guidelines and applicable local law.
Job DescriptionJob DescriptionThe incumbent will be responsible for supporting the Computerized System project teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. Will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements. Contributes expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments. Develops and evaluates quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements. Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications. Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports. Coordinate implementation validation/qualification strategies and serve as the subject matter expert. Present project status reports to management as well as project teams. Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes. Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements. Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report. Support internal, client, and regulatory audits and inspections. Generate or review/update computer system related policies, procedures, templates, forms, etc. Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP's regulations, GAMP, industry standards, policies and procedures. Performs other quality system related duties as necessary. REQUIREMENTS Bachelor's Degree in a Scientific or Engineering discipline 8 + years of computerized system experience with IT compliance/validation/qualification activities. 8 + years of experience working in an FDA-regulated, GxP-related environment. Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance. Comprehensive knowledge in Software Validation and Data Integrity Principles. Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations. Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models. Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems. Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ). Knowledge of Software Risk Management Principles and tools. Knowledge and proven ability working with Risk Management methodologies and tools. Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus. Experience with application system validation and infrastructure qualification. Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus. Experience with writing and approving Standard Operating Procedures and Quality Standards. 10% travel required. Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint). Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams. Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers. Solid organizational and time management skills, proven project management, presentation and facilitation skills. Innovation and strategic compliance skills including looking internally and externally for best practices. The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems. The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities. The ability to enable and drive change while being focused on internal and external customers. Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines. Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
09/25/2026
Full time
Job DescriptionJob DescriptionThe incumbent will be responsible for supporting the Computerized System project teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. Will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements. Contributes expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments. Develops and evaluates quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements. Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications. Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports. Coordinate implementation validation/qualification strategies and serve as the subject matter expert. Present project status reports to management as well as project teams. Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes. Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements. Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report. Support internal, client, and regulatory audits and inspections. Generate or review/update computer system related policies, procedures, templates, forms, etc. Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP's regulations, GAMP, industry standards, policies and procedures. Performs other quality system related duties as necessary. REQUIREMENTS Bachelor's Degree in a Scientific or Engineering discipline 8 + years of computerized system experience with IT compliance/validation/qualification activities. 8 + years of experience working in an FDA-regulated, GxP-related environment. Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance. Comprehensive knowledge in Software Validation and Data Integrity Principles. Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations. Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models. Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems. Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ). Knowledge of Software Risk Management Principles and tools. Knowledge and proven ability working with Risk Management methodologies and tools. Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus. Experience with application system validation and infrastructure qualification. Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus. Experience with writing and approving Standard Operating Procedures and Quality Standards. 10% travel required. Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint). Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams. Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers. Solid organizational and time management skills, proven project management, presentation and facilitation skills. Innovation and strategic compliance skills including looking internally and externally for best practices. The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems. The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities. The ability to enable and drive change while being focused on internal and external customers. Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines. Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Job DescriptionJob DescriptionThe incumbent will be responsible for supporting the Computerized System project teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. Will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements. Contributes expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments. Develops and evaluates quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements. Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications. Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports. Coordinate implementation validation/qualification strategies and serve as the subject matter expert. Present project status reports to management as well as project teams. Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes. Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements. Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report. Support internal, client, and regulatory audits and inspections. Generate or review/update computer system related policies, procedures, templates, forms, etc. Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP's regulations, GAMP, industry standards, policies and procedures. Performs other quality system related duties as necessary. REQUIREMENTS Bachelor's Degree in a Scientific or Engineering discipline 8 + years of computerized system experience with IT compliance/validation/qualification activities. 8 + years of experience working in an FDA-regulated, GxP-related environment. Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance. Comprehensive knowledge in Software Validation and Data Integrity Principles. Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations. Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models. Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems. Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ). Knowledge of Software Risk Management Principles and tools. Knowledge and proven ability working with Risk Management methodologies and tools. Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus. Experience with application system validation and infrastructure qualification. Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus. Experience with writing and approving Standard Operating Procedures and Quality Standards. 10% travel required. Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint). Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams. Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers. Solid organizational and time management skills, proven project management, presentation and facilitation skills. Innovation and strategic compliance skills including looking internally and externally for best practices. The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems. The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities. The ability to enable and drive change while being focused on internal and external customers. Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines. Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
09/25/2026
Full time
Job DescriptionJob DescriptionThe incumbent will be responsible for supporting the Computerized System project teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. Will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements. Contributes expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments. Develops and evaluates quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements. Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications. Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports. Coordinate implementation validation/qualification strategies and serve as the subject matter expert. Present project status reports to management as well as project teams. Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes. Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements. Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report. Support internal, client, and regulatory audits and inspections. Generate or review/update computer system related policies, procedures, templates, forms, etc. Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP's regulations, GAMP, industry standards, policies and procedures. Performs other quality system related duties as necessary. REQUIREMENTS Bachelor's Degree in a Scientific or Engineering discipline 8 + years of computerized system experience with IT compliance/validation/qualification activities. 8 + years of experience working in an FDA-regulated, GxP-related environment. Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance. Comprehensive knowledge in Software Validation and Data Integrity Principles. Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations. Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models. Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems. Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ). Knowledge of Software Risk Management Principles and tools. Knowledge and proven ability working with Risk Management methodologies and tools. Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus. Experience with application system validation and infrastructure qualification. Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus. Experience with writing and approving Standard Operating Procedures and Quality Standards. 10% travel required. Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint). Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams. Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers. Solid organizational and time management skills, proven project management, presentation and facilitation skills. Innovation and strategic compliance skills including looking internally and externally for best practices. The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems. The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities. The ability to enable and drive change while being focused on internal and external customers. Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines. Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Job DescriptionJob Description Overview Are you looking for a career you can feel good about? We hire only those that strive to do their best. By joining our family, you'll receive the honor and recognition that comes with working for the industry's global leader in evidenced based rehabilitation. Who We Are: GEO provides complementary, turnkey solutions for numerous government partners worldwide across a spectrum of diversified correctional and community reentry services. From the development of state-of-the-art facilities and the provision of management services and evidence-based rehabilitation to the post-release reintegration and supervision of individuals in the community, GEO offers fully diversified, cost-effective services that deliver enhanced quality and improved outcomes. Why Work for GEO: We believe that work is more than a place you go to every day. It is about being inspired and motivated to achieve extraordinary things. Employee benefits play an important role in making The GEO Group a great place to work. At GEO, we believe in the three pillars of employee wellbeing: physical, emotional, and financial. With comprehensive benefits and competitive wages, we trust that you will find all the resources you need here to be successful. Responsibilities Summary The Manager of Contract Compliance primary responsibility is to support the contract compliance department's project management initiatives. This position is responsible for data management, reporting, process improvement initiatives, research, and analysis within the contract compliance department. This position provides applicable training on contract compliance requirements and policies and makes recommendations based on their observations. This position provides support, as needed, to the American Correctional Association (ACA), and Prison Rape Elimination Act (PREA) divisions of the contract compliance department. Primary Duties and Responsibilities The Manager of Contract Compliance collects and independently analyzes results of compliance reviews to identify trends and suggest organizational responses to identified anomalies. Develops, prepares, and generates on-going and ad-hoc special reports pertaining to contract compliance and performance improvement issues. Manages performance indicators, outcome measures, and data to report on areas of improvement or concerns and recommends policy and audit tool revisions accordingly. Conducts research on current trends in information technology and client directives related to compliance and audit functions. Assists the compliance department by assisting audit teams, exercising independent judgment on contract compliance, accreditation, and certification determinations. Assists in reviewing PREA investigations and ACA reports completed at the facility level for thoroughness and compliance, as needed. Oversees and manages the organization's audit compliance database. Monitors and tracks compliance database functionality and content. Assists the Senior Director, Contract Compliance, in the analysis of audit tools, policies and procedures, contracts, accreditation/certification standards, and state and federal regulations to develop effective audit instruments and processes. Responsible for the monitoring, tracking, revising, and developing compliance audit instruments and processes. Develops and provides quality control program, ACA, and PREA training to corporate and facility level staff. Assists Senior Director, Contract Compliance, coordinating department's training conferences, as needed. Coordinates and oversees the response process for Contract Performance Assessment Reports for all applicable divisions ensuring responses are provided in a thorough and timely manner. Conducts research for project implementation. Performs other duties as assigned. Qualifications Minimum Requirements Bachelor's degree from an accredited college or university and five (5) years of professional experience in a Corrections, Law Enforcement, or related capacity. (A high school diploma with seven (7) years of progressive experience in the above fields may be substituted at the discretion of management). Two (2) years direct experience in ensuring adherence to compliance policies and procedures. Experience in management and administrative procedures with exceptional writing skills and computer literacy. Ability to work with minimal supervision. Well organized, multi-task oriented. Must be available for periodic travel. Must be willing to periodically work within prison environments. Must be able to pass a background investigation. Ability to work with computers and the applicable software used by the department. The GEO Group, Inc.
09/25/2026
Full time
Job DescriptionJob Description Overview Are you looking for a career you can feel good about? We hire only those that strive to do their best. By joining our family, you'll receive the honor and recognition that comes with working for the industry's global leader in evidenced based rehabilitation. Who We Are: GEO provides complementary, turnkey solutions for numerous government partners worldwide across a spectrum of diversified correctional and community reentry services. From the development of state-of-the-art facilities and the provision of management services and evidence-based rehabilitation to the post-release reintegration and supervision of individuals in the community, GEO offers fully diversified, cost-effective services that deliver enhanced quality and improved outcomes. Why Work for GEO: We believe that work is more than a place you go to every day. It is about being inspired and motivated to achieve extraordinary things. Employee benefits play an important role in making The GEO Group a great place to work. At GEO, we believe in the three pillars of employee wellbeing: physical, emotional, and financial. With comprehensive benefits and competitive wages, we trust that you will find all the resources you need here to be successful. Responsibilities Summary The Manager of Contract Compliance primary responsibility is to support the contract compliance department's project management initiatives. This position is responsible for data management, reporting, process improvement initiatives, research, and analysis within the contract compliance department. This position provides applicable training on contract compliance requirements and policies and makes recommendations based on their observations. This position provides support, as needed, to the American Correctional Association (ACA), and Prison Rape Elimination Act (PREA) divisions of the contract compliance department. Primary Duties and Responsibilities The Manager of Contract Compliance collects and independently analyzes results of compliance reviews to identify trends and suggest organizational responses to identified anomalies. Develops, prepares, and generates on-going and ad-hoc special reports pertaining to contract compliance and performance improvement issues. Manages performance indicators, outcome measures, and data to report on areas of improvement or concerns and recommends policy and audit tool revisions accordingly. Conducts research on current trends in information technology and client directives related to compliance and audit functions. Assists the compliance department by assisting audit teams, exercising independent judgment on contract compliance, accreditation, and certification determinations. Assists in reviewing PREA investigations and ACA reports completed at the facility level for thoroughness and compliance, as needed. Oversees and manages the organization's audit compliance database. Monitors and tracks compliance database functionality and content. Assists the Senior Director, Contract Compliance, in the analysis of audit tools, policies and procedures, contracts, accreditation/certification standards, and state and federal regulations to develop effective audit instruments and processes. Responsible for the monitoring, tracking, revising, and developing compliance audit instruments and processes. Develops and provides quality control program, ACA, and PREA training to corporate and facility level staff. Assists Senior Director, Contract Compliance, coordinating department's training conferences, as needed. Coordinates and oversees the response process for Contract Performance Assessment Reports for all applicable divisions ensuring responses are provided in a thorough and timely manner. Conducts research for project implementation. Performs other duties as assigned. Qualifications Minimum Requirements Bachelor's degree from an accredited college or university and five (5) years of professional experience in a Corrections, Law Enforcement, or related capacity. (A high school diploma with seven (7) years of progressive experience in the above fields may be substituted at the discretion of management). Two (2) years direct experience in ensuring adherence to compliance policies and procedures. Experience in management and administrative procedures with exceptional writing skills and computer literacy. Ability to work with minimal supervision. Well organized, multi-task oriented. Must be available for periodic travel. Must be willing to periodically work within prison environments. Must be able to pass a background investigation. Ability to work with computers and the applicable software used by the department. The GEO Group, Inc.
Job DescriptionJob Description Overview Are you looking for a career you can feel good about? We hire only those that strive to do their best. By joining our family, you'll receive the honor and recognition that comes with working for the industry's global leader in evidenced based rehabilitation. Who We Are: GEO provides complementary, turnkey solutions for numerous government partners worldwide across a spectrum of diversified correctional and community reentry services. From the development of state-of-the-art facilities and the provision of management services and evidence-based rehabilitation to the post-release reintegration and supervision of individuals in the community, GEO offers fully diversified, cost-effective services that deliver enhanced quality and improved outcomes. Why Work for GEO: We believe that work is more than a place you go to every day. It is about being inspired and motivated to achieve extraordinary things. Employee benefits play an important role in making The GEO Group a great place to work. At GEO, we believe in the three pillars of employee wellbeing: physical, emotional, and financial. With comprehensive benefits and competitive wages, we trust that you will find all the resources you need here to be successful. Responsibilities Summary The Manager of Contract Compliance primary responsibility is to support the contract compliance department's project management initiatives. This position is responsible for data management, reporting, process improvement initiatives, research, and analysis within the contract compliance department. This position provides applicable training on contract compliance requirements and policies and makes recommendations based on their observations. This position provides support, as needed, to the American Correctional Association (ACA), and Prison Rape Elimination Act (PREA) divisions of the contract compliance department. Primary Duties and Responsibilities The Manager of Contract Compliance collects and independently analyzes results of compliance reviews to identify trends and suggest organizational responses to identified anomalies. Develops, prepares, and generates on-going and ad-hoc special reports pertaining to contract compliance and performance improvement issues. Manages performance indicators, outcome measures, and data to report on areas of improvement or concerns and recommends policy and audit tool revisions accordingly. Conducts research on current trends in information technology and client directives related to compliance and audit functions. Assists the compliance department by assisting audit teams, exercising independent judgment on contract compliance, accreditation, and certification determinations. Assists in reviewing PREA investigations and ACA reports completed at the facility level for thoroughness and compliance, as needed. Oversees and manages the organization's audit compliance database. Monitors and tracks compliance database functionality and content. Assists the Senior Director, Contract Compliance, in the analysis of audit tools, policies and procedures, contracts, accreditation/certification standards, and state and federal regulations to develop effective audit instruments and processes. Responsible for the monitoring, tracking, revising, and developing compliance audit instruments and processes. Develops and provides quality control program, ACA, and PREA training to corporate and facility level staff. Assists Senior Director, Contract Compliance, coordinating department's training conferences, as needed. Coordinates and oversees the response process for Contract Performance Assessment Reports for all applicable divisions ensuring responses are provided in a thorough and timely manner. Conducts research for project implementation. Performs other duties as assigned. Qualifications Minimum Requirements Bachelor's degree from an accredited college or university and five (5) years of professional experience in a Corrections, Law Enforcement, or related capacity. (A high school diploma with seven (7) years of progressive experience in the above fields may be substituted at the discretion of management). Two (2) years direct experience in ensuring adherence to compliance policies and procedures. Experience in management and administrative procedures with exceptional writing skills and computer literacy. Ability to work with minimal supervision. Well organized, multi-task oriented. Must be available for periodic travel. Must be willing to periodically work within prison environments. Must be able to pass a background investigation. Ability to work with computers and the applicable software used by the department. The GEO Group, Inc.
09/25/2026
Full time
Job DescriptionJob Description Overview Are you looking for a career you can feel good about? We hire only those that strive to do their best. By joining our family, you'll receive the honor and recognition that comes with working for the industry's global leader in evidenced based rehabilitation. Who We Are: GEO provides complementary, turnkey solutions for numerous government partners worldwide across a spectrum of diversified correctional and community reentry services. From the development of state-of-the-art facilities and the provision of management services and evidence-based rehabilitation to the post-release reintegration and supervision of individuals in the community, GEO offers fully diversified, cost-effective services that deliver enhanced quality and improved outcomes. Why Work for GEO: We believe that work is more than a place you go to every day. It is about being inspired and motivated to achieve extraordinary things. Employee benefits play an important role in making The GEO Group a great place to work. At GEO, we believe in the three pillars of employee wellbeing: physical, emotional, and financial. With comprehensive benefits and competitive wages, we trust that you will find all the resources you need here to be successful. Responsibilities Summary The Manager of Contract Compliance primary responsibility is to support the contract compliance department's project management initiatives. This position is responsible for data management, reporting, process improvement initiatives, research, and analysis within the contract compliance department. This position provides applicable training on contract compliance requirements and policies and makes recommendations based on their observations. This position provides support, as needed, to the American Correctional Association (ACA), and Prison Rape Elimination Act (PREA) divisions of the contract compliance department. Primary Duties and Responsibilities The Manager of Contract Compliance collects and independently analyzes results of compliance reviews to identify trends and suggest organizational responses to identified anomalies. Develops, prepares, and generates on-going and ad-hoc special reports pertaining to contract compliance and performance improvement issues. Manages performance indicators, outcome measures, and data to report on areas of improvement or concerns and recommends policy and audit tool revisions accordingly. Conducts research on current trends in information technology and client directives related to compliance and audit functions. Assists the compliance department by assisting audit teams, exercising independent judgment on contract compliance, accreditation, and certification determinations. Assists in reviewing PREA investigations and ACA reports completed at the facility level for thoroughness and compliance, as needed. Oversees and manages the organization's audit compliance database. Monitors and tracks compliance database functionality and content. Assists the Senior Director, Contract Compliance, in the analysis of audit tools, policies and procedures, contracts, accreditation/certification standards, and state and federal regulations to develop effective audit instruments and processes. Responsible for the monitoring, tracking, revising, and developing compliance audit instruments and processes. Develops and provides quality control program, ACA, and PREA training to corporate and facility level staff. Assists Senior Director, Contract Compliance, coordinating department's training conferences, as needed. Coordinates and oversees the response process for Contract Performance Assessment Reports for all applicable divisions ensuring responses are provided in a thorough and timely manner. Conducts research for project implementation. Performs other duties as assigned. Qualifications Minimum Requirements Bachelor's degree from an accredited college or university and five (5) years of professional experience in a Corrections, Law Enforcement, or related capacity. (A high school diploma with seven (7) years of progressive experience in the above fields may be substituted at the discretion of management). Two (2) years direct experience in ensuring adherence to compliance policies and procedures. Experience in management and administrative procedures with exceptional writing skills and computer literacy. Ability to work with minimal supervision. Well organized, multi-task oriented. Must be available for periodic travel. Must be willing to periodically work within prison environments. Must be able to pass a background investigation. Ability to work with computers and the applicable software used by the department. The GEO Group, Inc.
Job DescriptionJob DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements. Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments. Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements. Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications. Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports. Coordinate implementation validation/qualification strategies and serve as the subject matter expert. Present project status reports to management as well as project teams. Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes. Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements. Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report. Support internal, client, and regulatory audits and inspections. Generate or review/update computer system related policies, procedures, templates, forms, etc. Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP's regulations, GAMP, industry standards, policies and procedures. Performs other quality system related duties as necessary. REQUIREMENTS BA/BS Degree in a Scientific or Engineering discipline 8 + years experience computerized system experience with IT compliance/validation/qualification activities. 8 + years experience working in an FDA-regulated, GxP-related environment. Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance. Comprehensive knowledge in Software Validation and Data Integrity Principles. Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations. Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models. Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems. Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ). Knowledge of Software Risk Management Principles and tools. Knowledge and proven ability working with Risk Management methodologies and tools. Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus. Experience with application system validation and infrastructure qualification. Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus. Experience with writing and approving Standard Operating Procedures and Quality Standards. Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint). Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams. Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers. Solid organizational and time management skills, proven project management, presentation and facilitation skills. Innovation and strategic compliance skills including looking internally and externally for best practices. The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems. The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities. The ability to enable and drive change while being focused on internal and external customers. Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines. Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise. 10% travel required. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
09/25/2026
Full time
Job DescriptionJob DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements. Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments. Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements. Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications. Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports. Coordinate implementation validation/qualification strategies and serve as the subject matter expert. Present project status reports to management as well as project teams. Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes. Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements. Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report. Support internal, client, and regulatory audits and inspections. Generate or review/update computer system related policies, procedures, templates, forms, etc. Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP's regulations, GAMP, industry standards, policies and procedures. Performs other quality system related duties as necessary. REQUIREMENTS BA/BS Degree in a Scientific or Engineering discipline 8 + years experience computerized system experience with IT compliance/validation/qualification activities. 8 + years experience working in an FDA-regulated, GxP-related environment. Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance. Comprehensive knowledge in Software Validation and Data Integrity Principles. Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations. Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models. Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems. Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ). Knowledge of Software Risk Management Principles and tools. Knowledge and proven ability working with Risk Management methodologies and tools. Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus. Experience with application system validation and infrastructure qualification. Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus. Experience with writing and approving Standard Operating Procedures and Quality Standards. Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint). Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams. Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers. Solid organizational and time management skills, proven project management, presentation and facilitation skills. Innovation and strategic compliance skills including looking internally and externally for best practices. The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems. The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities. The ability to enable and drive change while being focused on internal and external customers. Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines. Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise. 10% travel required. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Job DescriptionJob DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements. Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments. Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements. Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications. Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports. Coordinate implementation validation/qualification strategies and serve as the subject matter expert. Present project status reports to management as well as project teams. Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes. Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements. Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report. Support internal, client, and regulatory audits and inspections. Generate or review/update computer system related policies, procedures, templates, forms, etc. Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP's regulations, GAMP, industry standards, policies and procedures. Performs other quality system related duties as necessary. REQUIREMENTS BA/BS Degree in a Scientific or Engineering discipline 8 + years experience computerized system experience with IT compliance/validation/qualification activities. 8 + years experience working in an FDA-regulated, GxP-related environment. Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance. Comprehensive knowledge in Software Validation and Data Integrity Principles. Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations. Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models. Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems. Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ). Knowledge of Software Risk Management Principles and tools. Knowledge and proven ability working with Risk Management methodologies and tools. Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus. Experience with application system validation and infrastructure qualification. Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus. Experience with writing and approving Standard Operating Procedures and Quality Standards. Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint). Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams. Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers. Solid organizational and time management skills, proven project management, presentation and facilitation skills. Innovation and strategic compliance skills including looking internally and externally for best practices. The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems. The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities. The ability to enable and drive change while being focused on internal and external customers. Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines. Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise. 10% travel required. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
09/25/2026
Full time
Job DescriptionJob DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements. Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments. Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements. Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications. Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports. Coordinate implementation validation/qualification strategies and serve as the subject matter expert. Present project status reports to management as well as project teams. Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes. Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements. Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report. Support internal, client, and regulatory audits and inspections. Generate or review/update computer system related policies, procedures, templates, forms, etc. Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP's regulations, GAMP, industry standards, policies and procedures. Performs other quality system related duties as necessary. REQUIREMENTS BA/BS Degree in a Scientific or Engineering discipline 8 + years experience computerized system experience with IT compliance/validation/qualification activities. 8 + years experience working in an FDA-regulated, GxP-related environment. Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance. Comprehensive knowledge in Software Validation and Data Integrity Principles. Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations. Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models. Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems. Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ). Knowledge of Software Risk Management Principles and tools. Knowledge and proven ability working with Risk Management methodologies and tools. Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus. Experience with application system validation and infrastructure qualification. Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus. Experience with writing and approving Standard Operating Procedures and Quality Standards. Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint). Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams. Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers. Solid organizational and time management skills, proven project management, presentation and facilitation skills. Innovation and strategic compliance skills including looking internally and externally for best practices. The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems. The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities. The ability to enable and drive change while being focused on internal and external customers. Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines. Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise. 10% travel required. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Job DescriptionJob DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements. Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments. Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements. Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications. Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports. Coordinate implementation validation/qualification strategies and serve as the subject matter expert. Present project status reports to management as well as project teams. Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes. Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements. Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report. Support internal, client, and regulatory audits and inspections. Generate or review/update computer system related policies, procedures, templates, forms, etc. Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP's regulations, GAMP, industry standards, policies and procedures. Performs other quality system related duties as necessary. REQUIREMENTS BA/BS Degree in a Scientific or Engineering discipline 8 + years experience computerized system experience with IT compliance/validation/qualification activities. 8 + years experience working in an FDA-regulated, GxP-related environment. Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance. Comprehensive knowledge in Software Validation and Data Integrity Principles. Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations. Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models. Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems. Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ). Knowledge of Software Risk Management Principles and tools. Knowledge and proven ability working with Risk Management methodologies and tools. Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus. Experience with application system validation and infrastructure qualification. Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus. Experience with writing and approving Standard Operating Procedures and Quality Standards. Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint). Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams. Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers. Solid organizational and time management skills, proven project management, presentation and facilitation skills. Innovation and strategic compliance skills including looking internally and externally for best practices. The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems. The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities. The ability to enable and drive change while being focused on internal and external customers. Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines. Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise. 10% travel required. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
09/25/2026
Full time
Job DescriptionJob DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements. Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments. Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements. Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications. Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports. Coordinate implementation validation/qualification strategies and serve as the subject matter expert. Present project status reports to management as well as project teams. Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes. Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements. Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report. Support internal, client, and regulatory audits and inspections. Generate or review/update computer system related policies, procedures, templates, forms, etc. Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP's regulations, GAMP, industry standards, policies and procedures. Performs other quality system related duties as necessary. REQUIREMENTS BA/BS Degree in a Scientific or Engineering discipline 8 + years experience computerized system experience with IT compliance/validation/qualification activities. 8 + years experience working in an FDA-regulated, GxP-related environment. Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance. Comprehensive knowledge in Software Validation and Data Integrity Principles. Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations. Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models. Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems. Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ). Knowledge of Software Risk Management Principles and tools. Knowledge and proven ability working with Risk Management methodologies and tools. Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus. Experience with application system validation and infrastructure qualification. Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus. Experience with writing and approving Standard Operating Procedures and Quality Standards. Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint). Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams. Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers. Solid organizational and time management skills, proven project management, presentation and facilitation skills. Innovation and strategic compliance skills including looking internally and externally for best practices. The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems. The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities. The ability to enable and drive change while being focused on internal and external customers. Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines. Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise. 10% travel required. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Job DescriptionJob DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements. Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments. Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements. Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications. Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports. Coordinate implementation validation/qualification strategies and serve as the subject matter expert. Present project status reports to management as well as project teams. Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes. Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements. Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report. Support internal, client, and regulatory audits and inspections. Generate or review/update computer system related policies, procedures, templates, forms, etc. Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP's regulations, GAMP, industry standards, policies and procedures. Performs other quality system related duties as necessary. REQUIREMENTS BA/BS Degree in a Scientific or Engineering discipline 8 + years experience computerized system experience with IT compliance/validation/qualification activities. 8 + years experience working in an FDA-regulated, GxP-related environment. Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance. Comprehensive knowledge in Software Validation and Data Integrity Principles. Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations. Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models. Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems. Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ). Knowledge of Software Risk Management Principles and tools. Knowledge and proven ability working with Risk Management methodologies and tools. Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus. Experience with application system validation and infrastructure qualification. Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus. Experience with writing and approving Standard Operating Procedures and Quality Standards. Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint). Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams. Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers. Solid organizational and time management skills, proven project management, presentation and facilitation skills. Innovation and strategic compliance skills including looking internally and externally for best practices. The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems. The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities. The ability to enable and drive change while being focused on internal and external customers. Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines. Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise. 10% travel required. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
09/25/2026
Full time
Job DescriptionJob DescriptionSenior Manager IT Quality Assurance Validation Computerization Systems Allendale, NJ Lynkx Staffing LLC specializes in placing talented professionals in the Biotechnology, Pharmaceutical and Medical Devices IT & Human Resources disciplines in New Jersey. The Senior Manager IT Quality will be responsible for supporting the Computerized System Project Teams in the review and QA approval of system validation and infrastructure qualification documentation and protocols, in accordance with FDA regulations/guidelines, 21 CFR Part 11, EU Annex 11, GAMP5, ICH Q10 and latest industry practices. The incumbent will also be responsible for QA oversight of all GxP computerized system activities implementation projects for the company to ensure compliance with regulatory requirements. The scope includes working with multi-functional teams on system implementations, problem resolution, and process improvement projects. Assist in maintaining and, where applicable, improving the effectiveness of the computer system validation and data integrity program. Will participate in the execution of highly complex and specialized projects and must be innovative and practical in project validation problem-solving. Provide QA oversight and assurance that all GxP computerized system implementation and validation activities are executed in accordance with internal procedures and standards and meet all regulatory requirements. Contribute expertise and provides guidance in 21 CFR Part 11, GAMP5, and EU GMP Annex 11 requirements and data integrity principles and requirements as well as participates in assessments. Develop and evaluate quality processes and system standards to ensure compliance with company standards and governmental regulatory requirements. Work closely and collaboratively with various business partners including Information Technology and system owners to effectively and efficiently implement new computerized systems, system upgrades, or system modifications. Review and QA approve various types of system validation and infrastructure qualification documentation, including but not limited to, Master Plans, User Requirements and Functional Requirements Specifications, Design Specifications, IQ, OQ, PQ, Traceability Matrix, Validation protocols and reports. Coordinate implementation validation/qualification strategies and serve as the subject matter expert. Present project status reports to management as well as project teams. Review Change Control requests and assess impact to validation. Support the necessary computerized system validation activities for changes. Perform gap analysis of validation documentation, systems and practices. Communicate identified gaps including recommending and implementing corrective actions and improvements. Participate in supplier site Validation Assessments/Audits and assist to troubleshoot and improve systems and processes. Review corrective actions and implementation closure evidence of observations/recommendations identified in the report. Support internal, client, and regulatory audits and inspections. Generate or review/update computer system related policies, procedures, templates, forms, etc. Maintain up-to-date knowledge and understanding of quality system requirements as they apply to computerized system in accordance with cGxP's regulations, GAMP, industry standards, policies and procedures. Performs other quality system related duties as necessary. REQUIREMENTS BA/BS Degree in a Scientific or Engineering discipline 8 + years experience computerized system experience with IT compliance/validation/qualification activities. 8 + years experience working in an FDA-regulated, GxP-related environment. Demonstrated experience and expertise in 21 CFR Part 11 to ensuring site compliance. Comprehensive knowledge in Software Validation and Data Integrity Principles. Demonstrated experience, results, and accomplishments in QMS and LIMS system implementations. Working knowledge or expertise in Software validation practices and Software Development Life Cycle (SDLC) models. Working knowledge or expertise in Validations of Databases, Custom Software, Configurable Software, Non-Configurable Software, Infrastructure Software, Off-the-shelf software and various computerized systems. Working knowledge or expertise in Design Qualifications (DQ), Installation Qualifications (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ). Knowledge of Software Risk Management Principles and tools. Knowledge and proven ability working with Risk Management methodologies and tools. Comprehensive knowledge of GAMP5, 21 CFR Part 11, and EU Annex 11 as well as FDA 21 CFR Parts 210/211 (cGMP), ICH Q10, Eudralex Vol 4. Knowledge of PMDA regulations a plus. Experience with application system validation and infrastructure qualification. Experience with vendor audit for computer systems (IT infrastructure, validation etc.) a plus. Experience with writing and approving Standard Operating Procedures and Quality Standards. Proficient in Microsoft Office Suite (e.g., Word, Excel, Project, PowerPoint). Must have a participative management style, strong team development, coaching skills, and the ability to lead and motivate teams. Excellent verbal and written communication skills with the ability to communicate internally and externally to clients and suppliers. Solid organizational and time management skills, proven project management, presentation and facilitation skills. Innovation and strategic compliance skills including looking internally and externally for best practices. The ability to effectively build and maintain relationships with multiple departments in order to effectively solve problems. The ability to organize, prioritize and deliver tasks & projects with a sense of urgency under minimal supervision with attention to detail. Must be able to execute a variable workload with multiple priorities. The ability to enable and drive change while being focused on internal and external customers. Demonstrated results oriented, quick learner, team player; proactive with demonstrated ability to respond to urgent needs and deliver expected results within expected deadlines. Environment includes working with all levels of internal management and staff as well as with external clients, suppliers, and contractors. Work will be performed in both an office environment and a manufacturing facility, with exposure to varying degrees of ambient noise. 10% travel required. Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.
Daniel Defense LLC is seeking a Digital Commerce Senior Project Manager to lead complex eCommerce and digital initiatives supporting our premium firearms and accessories business. You will own end-to-end project delivery for website enhancements, digital sales capabilities, and customer experience improvements-scoping requirements, building roadmaps, managing vendors, and aligning stakeholders across IT, marketing, sales, and operations. You will track budgets, risks, and timelines, drive agile ceremonies, ensure compliance with security and regulatory standards, and use data to optimize conversion, performance, and scalability in a fast-paced, mission-focused environment. Responsibilities Lead end-to-end delivery of digital commerce and e Commerce projects Define project scope, requirements, timelines, and resource plans Coordinate cross-functional teams across IT, marketing, sales, and operations Manage external vendors, platforms, and implementation partners Oversee budgets, schedules, risks, and project reporting Drive agile ceremonies and ensure on-time, high-quality releases Ensure digital solutions meet security, compliance, and brand standards Analyze site performance, conversion, and user behavior to drive improvements Align digital commerce roadmap with business goals and growth targets Document processes and promote continuous improvement in project practices Required Skills Project managemente Commerce platform management Agile/Scrum methodologies Requirements gathering and documentation Budget and timeline management Vendor and stakeholder management Web analytics and conversion optimization Technical understanding of web technologies and integrations Risk management and compliance awareness Data-driven decision making
09/25/2026
Full time
Daniel Defense LLC is seeking a Digital Commerce Senior Project Manager to lead complex eCommerce and digital initiatives supporting our premium firearms and accessories business. You will own end-to-end project delivery for website enhancements, digital sales capabilities, and customer experience improvements-scoping requirements, building roadmaps, managing vendors, and aligning stakeholders across IT, marketing, sales, and operations. You will track budgets, risks, and timelines, drive agile ceremonies, ensure compliance with security and regulatory standards, and use data to optimize conversion, performance, and scalability in a fast-paced, mission-focused environment. Responsibilities Lead end-to-end delivery of digital commerce and e Commerce projects Define project scope, requirements, timelines, and resource plans Coordinate cross-functional teams across IT, marketing, sales, and operations Manage external vendors, platforms, and implementation partners Oversee budgets, schedules, risks, and project reporting Drive agile ceremonies and ensure on-time, high-quality releases Ensure digital solutions meet security, compliance, and brand standards Analyze site performance, conversion, and user behavior to drive improvements Align digital commerce roadmap with business goals and growth targets Document processes and promote continuous improvement in project practices Required Skills Project managemente Commerce platform management Agile/Scrum methodologies Requirements gathering and documentation Budget and timeline management Vendor and stakeholder management Web analytics and conversion optimization Technical understanding of web technologies and integrations Risk management and compliance awareness Data-driven decision making
