Job Description Job Description About the Role We are seeking a hands-on Senior Manager, SCM IT Systems to serve as the technical leader for our Supply Chain Management IT organization. This role combines deep functional/technical expertise in Oracle SCM applications with strong people and project leadership skills. The scope of this role is not limited to the current environment - it includes leading future upgrades and modernization efforts across the SCM application landscape (e.g., ASCP, Demantra, Agile, and related cloud/next-gen platforms). The ideal candidate can roll up their sleeves alongside a team of developers while also owning the day-to-day operational health of critical SCM systems and driving execution of strategic IT projects. What You'll Do Technical Leadership Serve as the subject matter expert and technical escalation point for Oracle SCM modules, including Advanced Supply Chain Planning (ASCP), Oracle Demantra (Demand Management/Planning), and Oracle Agile PLM. Lead planning and execution of upgrades and modernization initiatives across the SCM application landscape as the platform evolves beyond the current environment. Provide architectural guidance and hands-on technical direction to a team of developers and functional analysts. Review designs, code, and configurations to ensure solutions are scalable, maintainable, and aligned with best practices. Stay current on Oracle roadmap changes, patches, and upgrades relevant to the SCM application stack. Team Management Lead, mentor, and develop a team of developers and technical analysts across SCM systems. Set priorities, allocate resources, and balance workload across operational support and project initiatives. Foster a culture of accountability, collaboration, and continuous improvement within the team. Operations Management Own day-to-day operational stability of SCM systems, including incident management, root cause analysis, and preventive maintenance. Establish and monitor SLAs for system performance, uptime, and issue resolution. Manage change control, patching, and release processes for the SCM application landscape. Partner with infrastructure team and business partners to ensure system reliability and performance. Project Execution Plan and drive execution of SCM IT projects from requirements through deployment, including enhancements, upgrades, and new module rollouts. Manage project timelines, budgets, risks, and stakeholder communications. Coordinate with business stakeholders (Supply Chain, Planning, Procurement, Manufacturing) to translate business needs into technical solutions. Ensure proper testing, documentation, and change management practices are followed for all releases. Partner with business stakeholders to understand requirements and support the broader Supply Chain IT roadmap. Leverage AI and other data tools to deliver sound solutions that drive bottom-line value. Drive digital transformation initiatives using advanced tools and AI, and lead the roadmap for future tool upgrades. Who You Are Required Bachelor's degree in Computer Science, Information Systems, Engineering, or related field. Proven experience leading or managing a team of developers/analysts. Demonstrated experience managing both production support operations and project delivery simultaneously. Excellent stakeholder management and communication skills, with the ability to work across both technical and business teams. Oracle / SCM Technical Skills 10+ years of experience working with Oracle E-Business Suite SCM modules, including R12; experience leading upgrades or platform transitions is highly valued. Hands-on functional/technical experience with Oracle ASCP , and Oracle Demantra . Strong understanding of supply chain business processes (demand planning, supply planning, product lifecycle management). Preferred Oracle / SCM Related Experience with Oracle R12 integrations (e.g., Oracle Integration Cloud, EDI, middleware). Familiarity with SQL/PLSQL for troubleshooting and reporting. Experience with Oracle Discoverer reporting a plus. Experience with Oracle ERP reporting solutions (e.g., Oracle BI Publisher, OBIEE/Oracle Analytics Cloud, Oracle Reports, Hyperion/Essbase) a plus. Experience with Postgres databases a plus. Experience with Oracle Agile PLM a plus Broader Technology Skills Experience with cloud implementations (e.g., OCI, AWS, Azure) a plus. Familiarity with Java web technologies and streaming platforms (Kafka, Redpanda) a plus. Exposure to data analytics tools and practices a plus. Industry / Other Project management certification (PMP, Agile/Scrum) a plus. Prior experience in a manufacturing, distribution, or high-tech supply chain environment. Experience in the semiconductor industry a plus. Life at Diodes Diodes Incorporated delivers advanced analog and power semiconductor solutions to the world's leading technology companies, driving innovation, efficiency, and performance across high growth markets. Our teams collaborate across engineering, manufacturing, and corporate functions in a fast paced, transparent culture guided by Integrity, Commitment, and Innovation . We design reliable technology that improves the world-while prioritizing sustainability, safety, and employee well being. Our Vision: Inspire future technology through leading semiconductor solutions. Diodes Incorporated is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
10/24/2026
Full time
Job Description Job Description About the Role We are seeking a hands-on Senior Manager, SCM IT Systems to serve as the technical leader for our Supply Chain Management IT organization. This role combines deep functional/technical expertise in Oracle SCM applications with strong people and project leadership skills. The scope of this role is not limited to the current environment - it includes leading future upgrades and modernization efforts across the SCM application landscape (e.g., ASCP, Demantra, Agile, and related cloud/next-gen platforms). The ideal candidate can roll up their sleeves alongside a team of developers while also owning the day-to-day operational health of critical SCM systems and driving execution of strategic IT projects. What You'll Do Technical Leadership Serve as the subject matter expert and technical escalation point for Oracle SCM modules, including Advanced Supply Chain Planning (ASCP), Oracle Demantra (Demand Management/Planning), and Oracle Agile PLM. Lead planning and execution of upgrades and modernization initiatives across the SCM application landscape as the platform evolves beyond the current environment. Provide architectural guidance and hands-on technical direction to a team of developers and functional analysts. Review designs, code, and configurations to ensure solutions are scalable, maintainable, and aligned with best practices. Stay current on Oracle roadmap changes, patches, and upgrades relevant to the SCM application stack. Team Management Lead, mentor, and develop a team of developers and technical analysts across SCM systems. Set priorities, allocate resources, and balance workload across operational support and project initiatives. Foster a culture of accountability, collaboration, and continuous improvement within the team. Operations Management Own day-to-day operational stability of SCM systems, including incident management, root cause analysis, and preventive maintenance. Establish and monitor SLAs for system performance, uptime, and issue resolution. Manage change control, patching, and release processes for the SCM application landscape. Partner with infrastructure team and business partners to ensure system reliability and performance. Project Execution Plan and drive execution of SCM IT projects from requirements through deployment, including enhancements, upgrades, and new module rollouts. Manage project timelines, budgets, risks, and stakeholder communications. Coordinate with business stakeholders (Supply Chain, Planning, Procurement, Manufacturing) to translate business needs into technical solutions. Ensure proper testing, documentation, and change management practices are followed for all releases. Partner with business stakeholders to understand requirements and support the broader Supply Chain IT roadmap. Leverage AI and other data tools to deliver sound solutions that drive bottom-line value. Drive digital transformation initiatives using advanced tools and AI, and lead the roadmap for future tool upgrades. Who You Are Required Bachelor's degree in Computer Science, Information Systems, Engineering, or related field. Proven experience leading or managing a team of developers/analysts. Demonstrated experience managing both production support operations and project delivery simultaneously. Excellent stakeholder management and communication skills, with the ability to work across both technical and business teams. Oracle / SCM Technical Skills 10+ years of experience working with Oracle E-Business Suite SCM modules, including R12; experience leading upgrades or platform transitions is highly valued. Hands-on functional/technical experience with Oracle ASCP , and Oracle Demantra . Strong understanding of supply chain business processes (demand planning, supply planning, product lifecycle management). Preferred Oracle / SCM Related Experience with Oracle R12 integrations (e.g., Oracle Integration Cloud, EDI, middleware). Familiarity with SQL/PLSQL for troubleshooting and reporting. Experience with Oracle Discoverer reporting a plus. Experience with Oracle ERP reporting solutions (e.g., Oracle BI Publisher, OBIEE/Oracle Analytics Cloud, Oracle Reports, Hyperion/Essbase) a plus. Experience with Postgres databases a plus. Experience with Oracle Agile PLM a plus Broader Technology Skills Experience with cloud implementations (e.g., OCI, AWS, Azure) a plus. Familiarity with Java web technologies and streaming platforms (Kafka, Redpanda) a plus. Exposure to data analytics tools and practices a plus. Industry / Other Project management certification (PMP, Agile/Scrum) a plus. Prior experience in a manufacturing, distribution, or high-tech supply chain environment. Experience in the semiconductor industry a plus. Life at Diodes Diodes Incorporated delivers advanced analog and power semiconductor solutions to the world's leading technology companies, driving innovation, efficiency, and performance across high growth markets. Our teams collaborate across engineering, manufacturing, and corporate functions in a fast paced, transparent culture guided by Integrity, Commitment, and Innovation . We design reliable technology that improves the world-while prioritizing sustainability, safety, and employee well being. Our Vision: Inspire future technology through leading semiconductor solutions. Diodes Incorporated is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
This job is with Gilead Sciences Inc., an inclusive employer and a member of myGwork - the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Gilead Sciences is seeking a collaborative, hands-on leader to shape and deliver the ERP capabilities for a new, next-generation bulk drug substance manufacturing facility at our Foster City site. As the site's SAP business lead, you will translate operational needs into integrated processes across production, procurement, quality, and warehousing. Working closely with site stakeholders and the IT implementation team, you will define requirements, guide implementation, and connect SAP with other digital platforms to help create a compliant, paperless manufacturing environment. Required skills: Hands-on experience in warehousing, materials management, or production operations within a biologics or other GMP-regulated manufacturing environment. Strong systems expertise, including experience implementing an ERP platform such as SAP and leading the associated organizational change. A process-builder mindset, with the ability to move confidently from strategy and design to hands-on execution. Proven cross-functional leadership and the ability to align engineering, quality, materials management, manufacturing, and IT teams. A strong commitment to quality, cGMP compliance, operational excellence, and positive patient impact. Job Responsibilities: Own the digital backbone for materials Lead the design and implementation of SAP and supporting systems, bridging warehousing, logistics, and manufacturing execution to deliver a fully integrated, digital operation. Deliver across construction and systems build Align timelines and business deliverables between the digital infrastructure and the associated new facility construction to ensure a smooth startup. Drive a paperless, future-ready environment Champion digital transformation by implementing streamlined, compliant, and data-driven processes that eliminate paper and improve efficiency. Establish core material handling processes Define user requirements, use cases and process flows, procedures and training to ensure the ERP and integrated systems are qualified and ready to support GMP operations at launch. Integrate with existing operations Collaborate with established manufacturing sites to leverage best practices, ensure system consistency, and enable organizational alignment across sites. Influence future ERP footprint Support future enterprise ERP projects, representing the Foster City site manufacturing organization. Qualifications: Requires a Master's degree with 6+ years of relevant professional experience, or BS with 8+ years of relevant professional experience - a degree in a relevant scientific or business discipline is strongly preferred. Excellent organizational and communication (both written and verbal) skills. Experience in pharmaceutical operations/cGMP environment highly desirable. The ideal candidate would also have: Proven experience using and implementing SAP in a manufacturing or life sciences environment. Strong understanding of clinical and commercial manufacturing operations and warehouse management. Strategic thinking and ability to influence and constructively challenge the status quo. The salary range for this position is: $157,590.00 - $203,940.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans . For additional benefits information, visit: Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For jobs in the United States: Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex , age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.
10/24/2026
Full time
This job is with Gilead Sciences Inc., an inclusive employer and a member of myGwork - the largest global platform for the LGBTQ+ business community. Please do not contact the recruiter directly. At Gilead, we're creating a healthier world for all people. For more than 35 years, we've tackled diseases such as HIV, viral hepatitis, COVID-19 and cancer - working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the world's biggest health challenges, and our mission requires collaboration, determination and a relentless drive to make a difference. Every member of Gilead's team plays a critical role in the discovery and development of life-changing scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions, and we're looking for the next wave of passionate and ambitious people ready to make a direct impact. We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future, you are the key driver in evolving our culture and creating an environment where every employee feels included, developed and empowered to fulfil their aspirations. Join Gilead and help create possible, together. Job Description Gilead Sciences is seeking a collaborative, hands-on leader to shape and deliver the ERP capabilities for a new, next-generation bulk drug substance manufacturing facility at our Foster City site. As the site's SAP business lead, you will translate operational needs into integrated processes across production, procurement, quality, and warehousing. Working closely with site stakeholders and the IT implementation team, you will define requirements, guide implementation, and connect SAP with other digital platforms to help create a compliant, paperless manufacturing environment. Required skills: Hands-on experience in warehousing, materials management, or production operations within a biologics or other GMP-regulated manufacturing environment. Strong systems expertise, including experience implementing an ERP platform such as SAP and leading the associated organizational change. A process-builder mindset, with the ability to move confidently from strategy and design to hands-on execution. Proven cross-functional leadership and the ability to align engineering, quality, materials management, manufacturing, and IT teams. A strong commitment to quality, cGMP compliance, operational excellence, and positive patient impact. Job Responsibilities: Own the digital backbone for materials Lead the design and implementation of SAP and supporting systems, bridging warehousing, logistics, and manufacturing execution to deliver a fully integrated, digital operation. Deliver across construction and systems build Align timelines and business deliverables between the digital infrastructure and the associated new facility construction to ensure a smooth startup. Drive a paperless, future-ready environment Champion digital transformation by implementing streamlined, compliant, and data-driven processes that eliminate paper and improve efficiency. Establish core material handling processes Define user requirements, use cases and process flows, procedures and training to ensure the ERP and integrated systems are qualified and ready to support GMP operations at launch. Integrate with existing operations Collaborate with established manufacturing sites to leverage best practices, ensure system consistency, and enable organizational alignment across sites. Influence future ERP footprint Support future enterprise ERP projects, representing the Foster City site manufacturing organization. Qualifications: Requires a Master's degree with 6+ years of relevant professional experience, or BS with 8+ years of relevant professional experience - a degree in a relevant scientific or business discipline is strongly preferred. Excellent organizational and communication (both written and verbal) skills. Experience in pharmaceutical operations/cGMP environment highly desirable. The ideal candidate would also have: Proven experience using and implementing SAP in a manufacturing or life sciences environment. Strong understanding of clinical and commercial manufacturing operations and warehouse management. Strategic thinking and ability to influence and constructively challenge the status quo. The salary range for this position is: $157,590.00 - $203,940.00. Gilead considers a variety of factors when determining base compensation, including experience, qualifications, and geographic location. These considerations mean actual compensation will vary. This position may also be eligible for a discretionary annual bonus, discretionary stock-based long-term incentives (eligibility may vary based on role), paid time off, and a benefits package. Benefits include company-sponsored medical, dental, vision, and life insurance plans . For additional benefits information, visit: Eligible employees may participate in benefit plans, subject to the terms and conditions of the applicable plans. For jobs in the United States: Gilead Sciences Inc. is committed to providing equal employment opportunities to all employees and applicants for employment, and is dedicated to fostering an inclusive work environment comprised of diverse perspectives, backgrounds, and experiences. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, sex , age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job related characteristics or other prohibited grounds specified in applicable federal, state and local laws. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans' Readjustment Act of 1974, and Title I of the Americans with Disabilities Act of 1990, applicants who require accommodation in the job application process may contact for assistance. For more information about equal employment opportunity protections, please view the 'Know Your Rights' poster. NOTICE: EMPLOYEE POLYGRAPH PROTECTION ACT YOUR RIGHTS UNDER THE FAMILY AND MEDICAL LEAVE ACT Gilead Sciences will not discharge or in any other manner discriminate against employees or applicants because they have inquired about, discussed, or disclosed their own pay or the pay of another employee or applicant. However, employees who have access to the compensation information of other employees or applicants as a part of their essential job functions cannot disclose the pay of other employees or applicants to individuals who do not otherwise have access to compensation information, unless the disclosure is (a) in response to a formal complaint or charge, (b) in furtherance of an investigation, proceeding, hearing, or action, including an investigation conducted by the employer, (c) consistent with the legal duty to furnish information; or (d) otherwise protected by law. Our environment respects individual differences and recognizes each employee as an integral member of our company. Our workforce reflects these values and celebrates the individuals who make up our growing team. Gilead provides a work environment free of harassment and prohibited conduct. We promote and support individual differences and diversity of thoughts and opinion. For Current Gilead Employees and Contractors: Please apply via the Internal Career Opportunities portal in Workday.
Country: United States Job Location: Chicago Job Family: Data &Tech Type of contract: Unlimited-term Working mode: Hybrid work Job Id: 54152 Senior IT Solutions Manager - Operations At Bel, we are not just a company-we are a company on a Mission, built on 160 years of bold innovation, family values, and a commitment to social purpose. With beloved brands like Babybel , GoGo squeeZ , The Laughing Cow , and Boursin , our snacking solutions bring more than joy; they want to serve as a force for good. Our U.S. Mission? To help close the critical 80% nutrition gap by making it easier for Americans to eat more fruits, veggies, and dairy as part of their daily lives. The company has headquarters in Chicago and New York City and operates 4 manufacturing plants in Little Chute, WI; Brookings, SD; Traverse City, MI; and Nampa, ID. Job Description Summary Reporting directly to the Vice President of IT, the IT Sr Solutions Manager - Operations (NorAm) plays a pivotal role in shaping and delivering IT solutions that drive operational excellence. This dynamic position focuses on designing, managing, and optimizing IT systems and processes to enhance efficiency, quality, and functionality across Purchasing, Supply Chain and Manufacturing operations. The Solution Manager will work in close partnership with NorAm Purchasing, Supply Chain and Operations leaders while collaborating with global and Local IT Operations teams. As a strategic partner, this role ensures alignment between technological initiatives and business goals and actively supports data-driven decision-making to deliver impactful results. This is a role based in Chicago. Essential Duties and Responsibilities Strategic Business Partner - optimizing IT systems and processes across Supply Chain, Purchasing and Operations Provides strategic guidance to optimize IT systems and processes, ensuring alignment with organizational goals and operational efficiency. Collaborate closely with Supply Chain, Purchasing and Operations stakeholders to anticipate technological needs, identify challenges, and implement solutions that enhance and streamline business processes. Proactively evaluates emerging technologies and industry trends, assessing their potential value and recommending data-driven, strategic initiatives to strengthen the organization's competitive edge. Application Management - responsible for end-to-end operation's technology solutions Operational Support and Adoption: Serve as the primary point of contact for Purchasing, Supply Chain and Operations teams, providing comprehensive support and fostering seamless adoption of IT solutions to improve efficiency and productivity. Guide cross-functional teams in maximizing the value of IT solutions through training, communication, and hands-on collaboration. System Performance and Reliability: Ensure stable and reliable IT systems under their responsibility by continuously monitoring performance, conducting root cause analysis, and implementing corrective actions to resolve issues proactively. Maintain a high level of data accuracy and system functionality to meet business and operational needs. Global Project Engagement: Actively participate in global initiatives affecting Operations, ensuring alignment between regional needs and group-level IT systems. Identify opportunities to leverage and customize existing global IT solutions for regional implementation while ensuring business continuity. Project Portfolio Management: Oversee a comprehensive portfolio of IT and operations projects, ensuring alignment with organizational governance processes and strategic objectives. Evaluate project priorities, perform risk assessments, and deliver results in line with deadlines. Implementation and Maintenance of IT Solutions: Lead the full lifecycle of IT solution implementation, including planning, configuration, and ongoing maintenance, ensuring projects are delivered on time, within scope, and within budget. Collaborate with stakeholders to continuously enhance system capabilities and address emerging business needs. Vendor Performance and Relationship Management: Oversee vendor relationships by managing performance, monitoring service-level agreements (SLAs), and ensuring partners consistently deliver on contractual obligations. Lead contract negotiations with vendors to secure favorable terms, balancing cost efficiency with the need for high-quality IT solutions and services. Act as the primary point of escalation for vendor-related issues, driving swift resolution to minimize disruptions to operations. Qualifications and Skills Education Bachelor's degree in IT, Supply Chain Management, Operations Management or a related field. A master's degree is preferred. Experience Minimum of 8 years IT leadership experience with a focus on Purchasing and Supply Chain systems for Manufacturing or CPG industry. Demonstrated experience implementing ERP and Supply Chain planning solutions (SAP strongly preferred); Demonstrated experience overseeing a comprehensive portfolio of IT and operations projects, ensuring alignment with organizational governance processes and corporate strategic objectives. Experience leading full lifecycle of IT solution implementation, including planning, configuration, and ongoing maintenance, ensuring projects are delivered on time, within scope, and within budget. Demonstrated experience in project leadership, project management, and vendor management. Skills Excellent analytical and problem-solving skills, with the ability to think strategically and make data-driven decisions. Strong verbal and written communication skills. Strong interpersonal skills and ability collaborate effectively across various levels within the organization. Demonstrates effective listening skills; regularly handles difficult customers or situations effectively requiring sensitivity and diplomacy. Ability to understand business processes and challenge users when appropriate. Ability to design and implement end-to-end solutions, including both technical and functional expertise to get the job done. Ability to collaborate effectively with cross-functional teams as well as IT resources. Ability to work independently with only general direction; appropriately keeps management informed of relevant issues. PHYSICAL REQUIREMENTS Must be able work in normal office conditions for a minimum of 8 hours per day. Must be able to travel intermittently via airplane within the U.S. and internationally. Working Conditions Work is performed largely in a hybrid office environment (2-3 days/week in office). Hours of work will generally be during regular business hours with at least 40 hours a week. At times there will be some variation in work hours due to special projects, deadlines and other business needs. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Travel Expectations: 15-25% Acknowledgement This job description describes the general nature and level of work performed by employee assigned to this position. It does not state or imply that these are the only duties and responsibilities assigned to the job. The employee may be required to perform other job-related duties as requested by manager and/or organization. All requirements are subject to change over time and to possible modifications to reasonably accommodate individuals with a disability. Total Rewards Base Salary: $170,000 - $180,000 Bonus Opportunity: 23% PTO and Medical, Dental and Vision Benefits from Day 1 401k Match Hybrid work schedule in Chicago Bel Brands is an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status or any other basis protected by applicable federal, state, or local laws. Bel Brands also prohibits harassment of applicants or employees based on any of these protected categories. It is also Bel Brand's policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions. Bel Brands is committed to recruiting, hiring and promoting people with disabilities and veterans. If you need an accommodation or assistance in using the website, please call . If you think that this job is for you, please click now on the button "Apply". Compensation details: 00 Yearly Salary PIe447b09ab76b-4318
10/21/2026
Full time
Country: United States Job Location: Chicago Job Family: Data &Tech Type of contract: Unlimited-term Working mode: Hybrid work Job Id: 54152 Senior IT Solutions Manager - Operations At Bel, we are not just a company-we are a company on a Mission, built on 160 years of bold innovation, family values, and a commitment to social purpose. With beloved brands like Babybel , GoGo squeeZ , The Laughing Cow , and Boursin , our snacking solutions bring more than joy; they want to serve as a force for good. Our U.S. Mission? To help close the critical 80% nutrition gap by making it easier for Americans to eat more fruits, veggies, and dairy as part of their daily lives. The company has headquarters in Chicago and New York City and operates 4 manufacturing plants in Little Chute, WI; Brookings, SD; Traverse City, MI; and Nampa, ID. Job Description Summary Reporting directly to the Vice President of IT, the IT Sr Solutions Manager - Operations (NorAm) plays a pivotal role in shaping and delivering IT solutions that drive operational excellence. This dynamic position focuses on designing, managing, and optimizing IT systems and processes to enhance efficiency, quality, and functionality across Purchasing, Supply Chain and Manufacturing operations. The Solution Manager will work in close partnership with NorAm Purchasing, Supply Chain and Operations leaders while collaborating with global and Local IT Operations teams. As a strategic partner, this role ensures alignment between technological initiatives and business goals and actively supports data-driven decision-making to deliver impactful results. This is a role based in Chicago. Essential Duties and Responsibilities Strategic Business Partner - optimizing IT systems and processes across Supply Chain, Purchasing and Operations Provides strategic guidance to optimize IT systems and processes, ensuring alignment with organizational goals and operational efficiency. Collaborate closely with Supply Chain, Purchasing and Operations stakeholders to anticipate technological needs, identify challenges, and implement solutions that enhance and streamline business processes. Proactively evaluates emerging technologies and industry trends, assessing their potential value and recommending data-driven, strategic initiatives to strengthen the organization's competitive edge. Application Management - responsible for end-to-end operation's technology solutions Operational Support and Adoption: Serve as the primary point of contact for Purchasing, Supply Chain and Operations teams, providing comprehensive support and fostering seamless adoption of IT solutions to improve efficiency and productivity. Guide cross-functional teams in maximizing the value of IT solutions through training, communication, and hands-on collaboration. System Performance and Reliability: Ensure stable and reliable IT systems under their responsibility by continuously monitoring performance, conducting root cause analysis, and implementing corrective actions to resolve issues proactively. Maintain a high level of data accuracy and system functionality to meet business and operational needs. Global Project Engagement: Actively participate in global initiatives affecting Operations, ensuring alignment between regional needs and group-level IT systems. Identify opportunities to leverage and customize existing global IT solutions for regional implementation while ensuring business continuity. Project Portfolio Management: Oversee a comprehensive portfolio of IT and operations projects, ensuring alignment with organizational governance processes and strategic objectives. Evaluate project priorities, perform risk assessments, and deliver results in line with deadlines. Implementation and Maintenance of IT Solutions: Lead the full lifecycle of IT solution implementation, including planning, configuration, and ongoing maintenance, ensuring projects are delivered on time, within scope, and within budget. Collaborate with stakeholders to continuously enhance system capabilities and address emerging business needs. Vendor Performance and Relationship Management: Oversee vendor relationships by managing performance, monitoring service-level agreements (SLAs), and ensuring partners consistently deliver on contractual obligations. Lead contract negotiations with vendors to secure favorable terms, balancing cost efficiency with the need for high-quality IT solutions and services. Act as the primary point of escalation for vendor-related issues, driving swift resolution to minimize disruptions to operations. Qualifications and Skills Education Bachelor's degree in IT, Supply Chain Management, Operations Management or a related field. A master's degree is preferred. Experience Minimum of 8 years IT leadership experience with a focus on Purchasing and Supply Chain systems for Manufacturing or CPG industry. Demonstrated experience implementing ERP and Supply Chain planning solutions (SAP strongly preferred); Demonstrated experience overseeing a comprehensive portfolio of IT and operations projects, ensuring alignment with organizational governance processes and corporate strategic objectives. Experience leading full lifecycle of IT solution implementation, including planning, configuration, and ongoing maintenance, ensuring projects are delivered on time, within scope, and within budget. Demonstrated experience in project leadership, project management, and vendor management. Skills Excellent analytical and problem-solving skills, with the ability to think strategically and make data-driven decisions. Strong verbal and written communication skills. Strong interpersonal skills and ability collaborate effectively across various levels within the organization. Demonstrates effective listening skills; regularly handles difficult customers or situations effectively requiring sensitivity and diplomacy. Ability to understand business processes and challenge users when appropriate. Ability to design and implement end-to-end solutions, including both technical and functional expertise to get the job done. Ability to collaborate effectively with cross-functional teams as well as IT resources. Ability to work independently with only general direction; appropriately keeps management informed of relevant issues. PHYSICAL REQUIREMENTS Must be able work in normal office conditions for a minimum of 8 hours per day. Must be able to travel intermittently via airplane within the U.S. and internationally. Working Conditions Work is performed largely in a hybrid office environment (2-3 days/week in office). Hours of work will generally be during regular business hours with at least 40 hours a week. At times there will be some variation in work hours due to special projects, deadlines and other business needs. The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions. Travel Expectations: 15-25% Acknowledgement This job description describes the general nature and level of work performed by employee assigned to this position. It does not state or imply that these are the only duties and responsibilities assigned to the job. The employee may be required to perform other job-related duties as requested by manager and/or organization. All requirements are subject to change over time and to possible modifications to reasonably accommodate individuals with a disability. Total Rewards Base Salary: $170,000 - $180,000 Bonus Opportunity: 23% PTO and Medical, Dental and Vision Benefits from Day 1 401k Match Hybrid work schedule in Chicago Bel Brands is an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, protected veteran status, disability status or any other basis protected by applicable federal, state, or local laws. Bel Brands also prohibits harassment of applicants or employees based on any of these protected categories. It is also Bel Brand's policy to comply with all applicable federal, state and local laws respecting consideration of unemployment status in making hiring decisions. Bel Brands is committed to recruiting, hiring and promoting people with disabilities and veterans. If you need an accommodation or assistance in using the website, please call . If you think that this job is for you, please click now on the button "Apply". Compensation details: 00 Yearly Salary PIe447b09ab76b-4318
Job Description Job Description Position Summary The Senior Manager, Data Integrity & Governance is responsible for leading and managing the Sharp Sterile Manufacturing site data integrity initiatives, with a focus on ensuring the accuracy, completeness, consistency, and reliability of GXP data across computerized and paper-based systems. The role will oversee the site's development, implementation, and monitoring of data integrity processes, policies, and tools that align with regulatory requirements, and enable adherence to ALCOA+ principles. The site Data Integrity Lead will work closely with the site functions including; IT, Manufacturing, Quality and Engineering to enable Data Integrity compliance using a Quality risk management approach. The site Data Integrity Lead will collaborate with the Director, Data Integrity at the Allentown site to ensure alignment with corporate initiatives and the consistent implementation of Data Integrity standards, governance practices, risk assessment methodologies, training programs, and continuous improvement activities across the organization. The primary responsibilities of this role include site training on the requirements of ALCOA+, ensuring processes and procedures are in place to implement ALCOA+ principles in paper and computerized systems, ensuring that computerized system access controls, audit trail reviews and back-up and restore functions are appropriately implemented and meet cGMP requirements. The site Data Integrity Lead will also have responsibility for implementing and maintaining risk-based methodologies for the assessment and management of data integrity risks. The site Data Integrity Lead will drive a Data Integrity Management program across the Lee, MA manufacturing facility. This site-based role requires a strong leader with excellent communication skills and who is capable of prioritizing and managing multiple projects effectively. The successful candidate will be responsible for ensuring cGMP compliance as it pertains to Data Integrity Management across site operations and for implementing applicable corporate standards locally. Duties and Responsibilities Lead and maintain the site Data Integrity Management Program, including defining site objectives and scope, implementing corporate data integrity requirements, development and refinement of site procedures, implementing processes and metrics to monitor the effectiveness of the site Data Integrity program. Serve as the site Data Integrity subject matter expert (SME) during regulatory inspections and client audits, train/coach personnel on ALCOA+ principles and associated regulations and guidance documents. (e.g. GAMP5, PIC/S, 21 CFR Part 11, EudraLex Annex 11, FDA's Guidance for Industry, "Data Integrity and Compliance with Drug CGMP: Questions and Answers" (Final, 2018 . Report to the Site Quality Head and serve on the site Quality Leadership team and governance forums. Provide leadership and guidance to site functional representatives and system or process owners supporting Data Integrity objectives. Ensure site personnel understand and implement risk-based methodologies are understood and implemented as they pertain to data integrity management, especially when assessing legacy computerized systems, when validating new computerized systems and when evaluating proposed changes to existing computerized systems. Collaborate with the applicable corporate and site Data Governance, Quality, and Information Technology functions to integrate data integrity into the overall data governance framework, with particular emphasis on computerized systems and adherence to ALCOA+ principles. Collaborate cross-site to ensure that roles and responsibilities are clear regarding data management and stewardship of data integrity management. Provide guidance on the process to evaluate data integrity compliance through audits of Sharp and its suppliers. Lead or support site Data Integrity risk assessments, investigations, root cause analyses, corrective and preventive actions, and remediation plans. Ensure Data Integrity considerations are incorporated into computerized system validation, change control, incident management, periodic review, and system retirement activities. Review and trend site Data Integrity metrics, communicate program status and risks to site leadership, and drive continuous improvement and inspection readiness. Monitor relevant regulatory and industry expectations, assess site impact, and coordinate implementation of required site actions. Regulatory Responsibilities Conduct business in a responsible manner that complies with all state, OSHA, and HIPAA regulations Maintain a detailed and comprehensive understanding of FDA, EU, and other regulatory agency requirements as it pertains to data integrity. Supervisory Responsibilities This position has no direct reporting line responsibility; however, it will provide functional leadership and oversight to Data Integrity representatives and subject matter experts embedded within site operational units to support the execution of the Data Integrity Program. Experience Prefer a minimum of 5 years of experience in data management, data governance frameworks, and data quality tools, with a focus on computerized systems and adherence to ALCOA+ principles. Also prefer a minimum of at least 1.5 years in a leadership role within a pharmaceutical operation. Expertise in the application of 21 CFR Part 11, EudraLex Annex 11 and GAMP standards for data integrity and validation of automated systems is required. Proven experience of managing data integrity initiatives, particularly in relation to computerized systems, within a pharmaceutical organization. Experience collaborating cross functionally on investigations, CAPAs, risk assessments, and remediation programs associated with Data Integrity events or observations. Demonstrated history of influencing, motivating and effecting change with cross functional teams. Ability to independently determine and develop approaches to address simple to complex issues. Knowledge of and skill in using computer software and hardware applications. Excellent verbal and written communication/documentation skills with a demonstrated ability to clearly present technical topics to a non technical audience. Ability to influence and engage stakeholders at all levels. Excellent project management skills with the ability to manage multiple initiatives simultaneously. Strong analytical skills with the ability to interpret complex data sets from computerized systems and provide actionable insights. Experience of working in a sterile pharmaceutical manufacturing environment preferred. Education BS or higher degree in an IT, engineering, scientific discipline or other related field. A master's degree is a plus. Knowledge, Skills & Abilities Skilled in the use of Microsoft office applications (Word, Excel, PowerPoint) and Adobe Acrobat High attention to detail Good writing, public speaking and presentation skills Must be able to travel approximately 10% of the time Physical Requirements Ability to sit for prolonged periods of time Ability to stand for prolong periods of time as required Able to lift up to 10lbs
10/20/2026
Full time
Job Description Job Description Position Summary The Senior Manager, Data Integrity & Governance is responsible for leading and managing the Sharp Sterile Manufacturing site data integrity initiatives, with a focus on ensuring the accuracy, completeness, consistency, and reliability of GXP data across computerized and paper-based systems. The role will oversee the site's development, implementation, and monitoring of data integrity processes, policies, and tools that align with regulatory requirements, and enable adherence to ALCOA+ principles. The site Data Integrity Lead will work closely with the site functions including; IT, Manufacturing, Quality and Engineering to enable Data Integrity compliance using a Quality risk management approach. The site Data Integrity Lead will collaborate with the Director, Data Integrity at the Allentown site to ensure alignment with corporate initiatives and the consistent implementation of Data Integrity standards, governance practices, risk assessment methodologies, training programs, and continuous improvement activities across the organization. The primary responsibilities of this role include site training on the requirements of ALCOA+, ensuring processes and procedures are in place to implement ALCOA+ principles in paper and computerized systems, ensuring that computerized system access controls, audit trail reviews and back-up and restore functions are appropriately implemented and meet cGMP requirements. The site Data Integrity Lead will also have responsibility for implementing and maintaining risk-based methodologies for the assessment and management of data integrity risks. The site Data Integrity Lead will drive a Data Integrity Management program across the Lee, MA manufacturing facility. This site-based role requires a strong leader with excellent communication skills and who is capable of prioritizing and managing multiple projects effectively. The successful candidate will be responsible for ensuring cGMP compliance as it pertains to Data Integrity Management across site operations and for implementing applicable corporate standards locally. Duties and Responsibilities Lead and maintain the site Data Integrity Management Program, including defining site objectives and scope, implementing corporate data integrity requirements, development and refinement of site procedures, implementing processes and metrics to monitor the effectiveness of the site Data Integrity program. Serve as the site Data Integrity subject matter expert (SME) during regulatory inspections and client audits, train/coach personnel on ALCOA+ principles and associated regulations and guidance documents. (e.g. GAMP5, PIC/S, 21 CFR Part 11, EudraLex Annex 11, FDA's Guidance for Industry, "Data Integrity and Compliance with Drug CGMP: Questions and Answers" (Final, 2018 . Report to the Site Quality Head and serve on the site Quality Leadership team and governance forums. Provide leadership and guidance to site functional representatives and system or process owners supporting Data Integrity objectives. Ensure site personnel understand and implement risk-based methodologies are understood and implemented as they pertain to data integrity management, especially when assessing legacy computerized systems, when validating new computerized systems and when evaluating proposed changes to existing computerized systems. Collaborate with the applicable corporate and site Data Governance, Quality, and Information Technology functions to integrate data integrity into the overall data governance framework, with particular emphasis on computerized systems and adherence to ALCOA+ principles. Collaborate cross-site to ensure that roles and responsibilities are clear regarding data management and stewardship of data integrity management. Provide guidance on the process to evaluate data integrity compliance through audits of Sharp and its suppliers. Lead or support site Data Integrity risk assessments, investigations, root cause analyses, corrective and preventive actions, and remediation plans. Ensure Data Integrity considerations are incorporated into computerized system validation, change control, incident management, periodic review, and system retirement activities. Review and trend site Data Integrity metrics, communicate program status and risks to site leadership, and drive continuous improvement and inspection readiness. Monitor relevant regulatory and industry expectations, assess site impact, and coordinate implementation of required site actions. Regulatory Responsibilities Conduct business in a responsible manner that complies with all state, OSHA, and HIPAA regulations Maintain a detailed and comprehensive understanding of FDA, EU, and other regulatory agency requirements as it pertains to data integrity. Supervisory Responsibilities This position has no direct reporting line responsibility; however, it will provide functional leadership and oversight to Data Integrity representatives and subject matter experts embedded within site operational units to support the execution of the Data Integrity Program. Experience Prefer a minimum of 5 years of experience in data management, data governance frameworks, and data quality tools, with a focus on computerized systems and adherence to ALCOA+ principles. Also prefer a minimum of at least 1.5 years in a leadership role within a pharmaceutical operation. Expertise in the application of 21 CFR Part 11, EudraLex Annex 11 and GAMP standards for data integrity and validation of automated systems is required. Proven experience of managing data integrity initiatives, particularly in relation to computerized systems, within a pharmaceutical organization. Experience collaborating cross functionally on investigations, CAPAs, risk assessments, and remediation programs associated with Data Integrity events or observations. Demonstrated history of influencing, motivating and effecting change with cross functional teams. Ability to independently determine and develop approaches to address simple to complex issues. Knowledge of and skill in using computer software and hardware applications. Excellent verbal and written communication/documentation skills with a demonstrated ability to clearly present technical topics to a non technical audience. Ability to influence and engage stakeholders at all levels. Excellent project management skills with the ability to manage multiple initiatives simultaneously. Strong analytical skills with the ability to interpret complex data sets from computerized systems and provide actionable insights. Experience of working in a sterile pharmaceutical manufacturing environment preferred. Education BS or higher degree in an IT, engineering, scientific discipline or other related field. A master's degree is a plus. Knowledge, Skills & Abilities Skilled in the use of Microsoft office applications (Word, Excel, PowerPoint) and Adobe Acrobat High attention to detail Good writing, public speaking and presentation skills Must be able to travel approximately 10% of the time Physical Requirements Ability to sit for prolonged periods of time Ability to stand for prolong periods of time as required Able to lift up to 10lbs
Job Description Job Description Description: Senior MES Engineer $145K-$180K + Bonus Raleigh, NC Hybrid Life Sciences MES / Industrial Automation Elizabeth Banzhaf, LPN Co-Founder & COO Heartline Staffing Call or Text: LinkedIn: View Elizabeth's LinkedIn Prefer a confidential conversation instead of applying? Call or text Elizabeth directly at . Heartline Staffing is recruiting a Senior MES Engineer for a senior-level Life Sciences manufacturing technology opportunity based in Raleigh, North Carolina. This position combines MES solution architecture, technical leadership, customer engagement, systems integration, project leadership and business development. The Senior MES Engineer will work directly with customers and lead engineering teams through requirements identification, MES platform evaluation, specification development, implementation, testing, commissioning and qualification. The role requires extensive MES experience, including at least 4 years of Life Sciences MES experience, and the ability to develop integrated manufacturing solutions across controls, MES and enterprise systems. COMPENSATION • $145,000-$180,000 Base Salary • Discretionary Bonus That Could Be 20%-35% • Relocation Assistance: No • Visa Sponsorship: No WORK MODEL • Hybrid Position Based In North Carolina • Candidate Must Live In North Carolina • Raleigh Office Presence Required Regularly, Particularly When Starting • Work Will Include Raleigh Office, Home Office And Client Sites Over Time • Up To 25% Travel MES SOLUTION ARCHITECTURE • Conceptualize, Detail And Implement MES Solutions For Industrial Processes And Machinery • Develop MES Strategies Integrating Process Knowledge, Equipment Design, Quality Standards And Information Technology • Design Solutions To Reduce Downtime, Support Regulatory Compliance And Improve Manufacturing Efficiency • Evaluate MES Platforms And Develop Technical Specifications • Lead Implementation, Testing, Start-Up, Commissioning And Qualification Activities • Support Whitefield And Brownfield System Architecture LIFE SCIENCES MES • Work With MES Solutions In Regulated Life Sciences Manufacturing Environments • Apply cGMP And 21 CFR Part 11 Requirements • Support Integrated EBR Recipe Design And Implementation • Apply GAMP5, S88 And S95 Standards • Understand GMP Warehouse And Inventory Management • Evaluate Manufacturing Processes And Recommend Optimal System Configurations MES PLATFORMS & SYSTEM INTEGRATION • Work With MES Platforms Including Werum PAS-X, Sepasoft And POMS • Coordinate Systems From Controls Through ERP • Integrate PLC / DCS Systems • Work With Historian Technology And Reporting Systems • Work With Relational Databases Including SQL And Oracle • Support Interfaces With Systems Such As DeltaV, SAP, LIMS, PI And Maximo • Apply Strong IT / OT Networking Knowledge TECHNICAL & PROJECT LEADERSHIP • Act As Technical Lead On MES Projects • Lead And Support Engineering Teams • Guide And Mentor Less Experienced Engineers And Technicians • Develop Project Execution Plans And Work Breakdown Structures • Support Project Budgets, Scheduling, Task Prioritization And Time Tracking • Support Financial Tracking And Reporting • Identify Project Problems Early And Support Conflict Resolution • Oversee Daily Project Operations And Activities On Projects Up To $1M • Support Overall Project Profitability • May Act As Project Manager On Smaller Projects CUSTOMER & BUSINESS DEVELOPMENT • Interact Directly With Customers • Build Strong Customer Partnerships • Support New And Existing Customer Relationships • Develop Repeat Business • Participate In Trade Shows And Associations • Contribute To Business Development And New Business Generation WORKING ENVIRONMENT • Standard Office Environment • Onsite Office Environment • Diverse Industrial Environments • Frequent Computer And Office Equipment Use • Position Includes Driving, Lifting, Pushing, Pulling And Mounting / Dismounting Equipment Requirements: • Bachelor Of Science Degree In Engineering, Computer Science Or Applied Sciences REQUIRED • Greater Than 8-10 Years Of Overall MES Experience REQUIRED • At Least 4 Years Of Life Sciences MES Experience REQUIRED • Ability To Live And Work In North Carolina REQUIRED • Ability To Travel Up To 25% REQUIRED • Ability To Act As A Solution Architect And Conceptualize, Detail And Implement MES Solutions For Industrial Processes And Machinery REQUIRED • Ability To Work Independently And Serve As Technical Lead While Guiding Lower-Level Engineers And Technicians REQUIRED • Familiarity With Life Sciences Regulatory Requirements Including cGMP And 21 CFR Part 11 REQUIRED • Experience Coordinating Multiple Systems From Controls Through ERP, Including PLC / DCS, Historian Technology, Reporting Systems, Relational Databases And ERP Systems, With Ability To Create Interfaces REQUIRED • Proven Experience Across MES Project Phases Including Conceptual, Basis Of Design, Implementation, Testing, Start-Up And Commissioning In The Life Sciences Industry REQUIRED • Whitefield And Brownfield System Architecture Experience REQUIRED • MES Solution Deployment Experience With Platforms Such As Werum PAS-X, Sepasoft Or POMS REQUIRED • Business Development Aptitude And Ability To Bring In Business REQUIRED PREFERRED • Experience Working For A Systems Integrator Or Similar Integration Environment • Interest And Capability To Grow Into Leadership Of An MES Office In North Carolina Not ready to formally apply? That's completely fine. Many senior MES professionals prefer a confidential conversation first. Call or text Elizabeth directly at .
10/20/2026
Full time
Job Description Job Description Description: Senior MES Engineer $145K-$180K + Bonus Raleigh, NC Hybrid Life Sciences MES / Industrial Automation Elizabeth Banzhaf, LPN Co-Founder & COO Heartline Staffing Call or Text: LinkedIn: View Elizabeth's LinkedIn Prefer a confidential conversation instead of applying? Call or text Elizabeth directly at . Heartline Staffing is recruiting a Senior MES Engineer for a senior-level Life Sciences manufacturing technology opportunity based in Raleigh, North Carolina. This position combines MES solution architecture, technical leadership, customer engagement, systems integration, project leadership and business development. The Senior MES Engineer will work directly with customers and lead engineering teams through requirements identification, MES platform evaluation, specification development, implementation, testing, commissioning and qualification. The role requires extensive MES experience, including at least 4 years of Life Sciences MES experience, and the ability to develop integrated manufacturing solutions across controls, MES and enterprise systems. COMPENSATION • $145,000-$180,000 Base Salary • Discretionary Bonus That Could Be 20%-35% • Relocation Assistance: No • Visa Sponsorship: No WORK MODEL • Hybrid Position Based In North Carolina • Candidate Must Live In North Carolina • Raleigh Office Presence Required Regularly, Particularly When Starting • Work Will Include Raleigh Office, Home Office And Client Sites Over Time • Up To 25% Travel MES SOLUTION ARCHITECTURE • Conceptualize, Detail And Implement MES Solutions For Industrial Processes And Machinery • Develop MES Strategies Integrating Process Knowledge, Equipment Design, Quality Standards And Information Technology • Design Solutions To Reduce Downtime, Support Regulatory Compliance And Improve Manufacturing Efficiency • Evaluate MES Platforms And Develop Technical Specifications • Lead Implementation, Testing, Start-Up, Commissioning And Qualification Activities • Support Whitefield And Brownfield System Architecture LIFE SCIENCES MES • Work With MES Solutions In Regulated Life Sciences Manufacturing Environments • Apply cGMP And 21 CFR Part 11 Requirements • Support Integrated EBR Recipe Design And Implementation • Apply GAMP5, S88 And S95 Standards • Understand GMP Warehouse And Inventory Management • Evaluate Manufacturing Processes And Recommend Optimal System Configurations MES PLATFORMS & SYSTEM INTEGRATION • Work With MES Platforms Including Werum PAS-X, Sepasoft And POMS • Coordinate Systems From Controls Through ERP • Integrate PLC / DCS Systems • Work With Historian Technology And Reporting Systems • Work With Relational Databases Including SQL And Oracle • Support Interfaces With Systems Such As DeltaV, SAP, LIMS, PI And Maximo • Apply Strong IT / OT Networking Knowledge TECHNICAL & PROJECT LEADERSHIP • Act As Technical Lead On MES Projects • Lead And Support Engineering Teams • Guide And Mentor Less Experienced Engineers And Technicians • Develop Project Execution Plans And Work Breakdown Structures • Support Project Budgets, Scheduling, Task Prioritization And Time Tracking • Support Financial Tracking And Reporting • Identify Project Problems Early And Support Conflict Resolution • Oversee Daily Project Operations And Activities On Projects Up To $1M • Support Overall Project Profitability • May Act As Project Manager On Smaller Projects CUSTOMER & BUSINESS DEVELOPMENT • Interact Directly With Customers • Build Strong Customer Partnerships • Support New And Existing Customer Relationships • Develop Repeat Business • Participate In Trade Shows And Associations • Contribute To Business Development And New Business Generation WORKING ENVIRONMENT • Standard Office Environment • Onsite Office Environment • Diverse Industrial Environments • Frequent Computer And Office Equipment Use • Position Includes Driving, Lifting, Pushing, Pulling And Mounting / Dismounting Equipment Requirements: • Bachelor Of Science Degree In Engineering, Computer Science Or Applied Sciences REQUIRED • Greater Than 8-10 Years Of Overall MES Experience REQUIRED • At Least 4 Years Of Life Sciences MES Experience REQUIRED • Ability To Live And Work In North Carolina REQUIRED • Ability To Travel Up To 25% REQUIRED • Ability To Act As A Solution Architect And Conceptualize, Detail And Implement MES Solutions For Industrial Processes And Machinery REQUIRED • Ability To Work Independently And Serve As Technical Lead While Guiding Lower-Level Engineers And Technicians REQUIRED • Familiarity With Life Sciences Regulatory Requirements Including cGMP And 21 CFR Part 11 REQUIRED • Experience Coordinating Multiple Systems From Controls Through ERP, Including PLC / DCS, Historian Technology, Reporting Systems, Relational Databases And ERP Systems, With Ability To Create Interfaces REQUIRED • Proven Experience Across MES Project Phases Including Conceptual, Basis Of Design, Implementation, Testing, Start-Up And Commissioning In The Life Sciences Industry REQUIRED • Whitefield And Brownfield System Architecture Experience REQUIRED • MES Solution Deployment Experience With Platforms Such As Werum PAS-X, Sepasoft Or POMS REQUIRED • Business Development Aptitude And Ability To Bring In Business REQUIRED PREFERRED • Experience Working For A Systems Integrator Or Similar Integration Environment • Interest And Capability To Grow Into Leadership Of An MES Office In North Carolina Not ready to formally apply? That's completely fine. Many senior MES professionals prefer a confidential conversation first. Call or text Elizabeth directly at .
Requisition Number: 74549 The company built on breakthroughs. Join us. Corning is one of the world's leading innovators in glass, ceramic, and materials science. From the depths of the ocean to the farthest reaches of space, our technologies push the boundaries of what's possible. How do we do this? With our people. They break through limitations and expectations - not once in a career, but every day. They help move our company, and the world, forward. At Corning, there are endless possibilities for making an impact. You can help connect the unconnected, drive the future of automobiles, transform at-home entertainment, and ensure the delivery of lifesaving medicines. And so much more. Come break through with us. Our Solar business delivers industry leading, U.S.-made solar components. We manufacture hyper-pure polysilicon, high-quality solar wafers, and innovative photovoltaic modules, leveraging our leadership in advanced manufacturing to serve growing energy demand. You will be a part of advancing critical U.S. supply chains and delivering unmatched quality and reliability to customers. Role Purpose The Application Engineering Manager will act as a technical liaison between AMPS and its solar module customers, providing expert-level support, designing solutions, and ensuring the successful implementation of our products and services. This role requires strong technical knowledge of solar products including solar modules, excellent communication skills, and the ability to collaborate across teams to deliver customer-focused solutions. Key Responsibilities Technical Support: Provide technical expertise and guidance to customers, answering inquiries, solving technical challenges, and ensuring optimal use of company products. Customer Collaboration: Work closely with solar customers to understand their requirements, challenges, and goals, and translate them into tailored solutions using company products and technologies. Product Demonstrations: Conduct product demonstrations, training sessions, and technical presentations to showcase product capabilities and benefits. Solution Design: Develop and propose application designs, configurations, or custom solutions that meet the specific needs of customers. Testing and Validation: Assist in product testing, troubleshooting, and validation to ensure compatibility and performance in customer applications. Project Management: Collaborate with internal teams-such as engineering, R&D, and sales-to manage customer projects and ensure timely delivery of solutions. Documentation: Prepare module technical documentation, manuals, solution briefs, and reports for internal and external use. Market Insights: Gather customer feedback and insights to help improve products, identify new application opportunities, and support product development initiatives. Experiences & Education Bachelor's degree in engineering (e.g., Electrical, Mechanical, Renewable Energy) or a related field. 3-5 years of experience in application engineering, technical support, or a similar role, preferably in the solar energy or renewable energy industry. Required Skills Strong technical knowledge of solar modules, photovoltaic systems, and energy storage solutions. Experience with solar simulation tools, system design software, or relevant engineering platforms Excellent problem-solving and analytical skills, with a deep understanding of solar energy technologies and applications. Exceptional communication and interpersonal skills, with the ability to explain complex technical concepts to diverse audiences, including non-technical stakeholders. Ability to multitask, prioritize, and manage time effectively in a fast-paced, customer-driven environment. Willingness to travel to customer sites as required. Desired Skills and Experiences >5 years' experience working in the solar energy industry, particularly with solar modules or photovoltaic systems. Familiarity with solar module manufacturing processes, performance testing, and quality standards. Knowledge of U.S. energy regulations and compliance requirements for solar technologies. Certifications in solar energy technologies or project management (e.g., NABCEP, PMP). This position does not support immigration sponsorship. The range for this position is $115,084.00 - $158,241.00 assuming full time status. Starting pay for the successful applicant is dependent on a variety of job-related factors, including but not limited to geographic location, market demands, experience, training, and education. A job that shapes a life. Corning offers you the total package. Your well-being is our priority. Our compensation and benefits package supports your health and wellness, financial aspirations, and career from day one. Company-wide bonuses and long-term incentives align with key business results and ensure you are rewarded when the company performs well. When Corning wins, we all win. As part of our commitment to your financial well-being, Corning provides company matching contributions to your 401(k) savings plan of up to 4% of pay when you contribute at least 6% of pay. Our health and well-being benefits include medical, dental, vision, paid parental leave, family building support, fitness, company-paid life insurance, disability, disease management programs, paid time off, and an Employee Assistance Program (EAP) to support you and your family. We prohibit discrimination on the basis of race, color, gender, age, religion, national origin, sexual orientation, gender identity or expression, disability, veteran status or any other legally protected status. Corning is committed to providing equal employment opportunities and considers requests for reasonable accommodations in accordance with applicable laws. Individuals with disabilities or sincerely held religious beliefs may request reasonable accommodations to participate in the application or interview process, perform essential job functions, or access other benefits and privileges of employment. To submit a request for reasonable accommodation related to disability or religion, please contact us at ?subject=Corning%20Accommodations .
10/20/2026
Full time
Requisition Number: 74549 The company built on breakthroughs. Join us. Corning is one of the world's leading innovators in glass, ceramic, and materials science. From the depths of the ocean to the farthest reaches of space, our technologies push the boundaries of what's possible. How do we do this? With our people. They break through limitations and expectations - not once in a career, but every day. They help move our company, and the world, forward. At Corning, there are endless possibilities for making an impact. You can help connect the unconnected, drive the future of automobiles, transform at-home entertainment, and ensure the delivery of lifesaving medicines. And so much more. Come break through with us. Our Solar business delivers industry leading, U.S.-made solar components. We manufacture hyper-pure polysilicon, high-quality solar wafers, and innovative photovoltaic modules, leveraging our leadership in advanced manufacturing to serve growing energy demand. You will be a part of advancing critical U.S. supply chains and delivering unmatched quality and reliability to customers. Role Purpose The Application Engineering Manager will act as a technical liaison between AMPS and its solar module customers, providing expert-level support, designing solutions, and ensuring the successful implementation of our products and services. This role requires strong technical knowledge of solar products including solar modules, excellent communication skills, and the ability to collaborate across teams to deliver customer-focused solutions. Key Responsibilities Technical Support: Provide technical expertise and guidance to customers, answering inquiries, solving technical challenges, and ensuring optimal use of company products. Customer Collaboration: Work closely with solar customers to understand their requirements, challenges, and goals, and translate them into tailored solutions using company products and technologies. Product Demonstrations: Conduct product demonstrations, training sessions, and technical presentations to showcase product capabilities and benefits. Solution Design: Develop and propose application designs, configurations, or custom solutions that meet the specific needs of customers. Testing and Validation: Assist in product testing, troubleshooting, and validation to ensure compatibility and performance in customer applications. Project Management: Collaborate with internal teams-such as engineering, R&D, and sales-to manage customer projects and ensure timely delivery of solutions. Documentation: Prepare module technical documentation, manuals, solution briefs, and reports for internal and external use. Market Insights: Gather customer feedback and insights to help improve products, identify new application opportunities, and support product development initiatives. Experiences & Education Bachelor's degree in engineering (e.g., Electrical, Mechanical, Renewable Energy) or a related field. 3-5 years of experience in application engineering, technical support, or a similar role, preferably in the solar energy or renewable energy industry. Required Skills Strong technical knowledge of solar modules, photovoltaic systems, and energy storage solutions. Experience with solar simulation tools, system design software, or relevant engineering platforms Excellent problem-solving and analytical skills, with a deep understanding of solar energy technologies and applications. Exceptional communication and interpersonal skills, with the ability to explain complex technical concepts to diverse audiences, including non-technical stakeholders. Ability to multitask, prioritize, and manage time effectively in a fast-paced, customer-driven environment. Willingness to travel to customer sites as required. Desired Skills and Experiences >5 years' experience working in the solar energy industry, particularly with solar modules or photovoltaic systems. Familiarity with solar module manufacturing processes, performance testing, and quality standards. Knowledge of U.S. energy regulations and compliance requirements for solar technologies. Certifications in solar energy technologies or project management (e.g., NABCEP, PMP). This position does not support immigration sponsorship. The range for this position is $115,084.00 - $158,241.00 assuming full time status. Starting pay for the successful applicant is dependent on a variety of job-related factors, including but not limited to geographic location, market demands, experience, training, and education. A job that shapes a life. Corning offers you the total package. Your well-being is our priority. Our compensation and benefits package supports your health and wellness, financial aspirations, and career from day one. Company-wide bonuses and long-term incentives align with key business results and ensure you are rewarded when the company performs well. When Corning wins, we all win. As part of our commitment to your financial well-being, Corning provides company matching contributions to your 401(k) savings plan of up to 4% of pay when you contribute at least 6% of pay. Our health and well-being benefits include medical, dental, vision, paid parental leave, family building support, fitness, company-paid life insurance, disability, disease management programs, paid time off, and an Employee Assistance Program (EAP) to support you and your family. We prohibit discrimination on the basis of race, color, gender, age, religion, national origin, sexual orientation, gender identity or expression, disability, veteran status or any other legally protected status. Corning is committed to providing equal employment opportunities and considers requests for reasonable accommodations in accordance with applicable laws. Individuals with disabilities or sincerely held religious beliefs may request reasonable accommodations to participate in the application or interview process, perform essential job functions, or access other benefits and privileges of employment. To submit a request for reasonable accommodation related to disability or religion, please contact us at ?subject=Corning%20Accommodations .
Job Description Job Description Position Summary The Senior Manager, Data Integrity & Governance is responsible for leading and managing the Sharp Sterile Manufacturing site data integrity initiatives, with a focus on ensuring the accuracy, completeness, consistency, and reliability of GXP data across computerized and paper-based systems. The role will oversee the site's development, implementation, and monitoring of data integrity processes, policies, and tools that align with regulatory requirements, and enable adherence to ALCOA+ principles. The site Data Integrity Lead will work closely with the site functions including; IT, Manufacturing, Quality and Engineering to enable Data Integrity compliance using a Quality risk management approach. The site Data Integrity Lead will collaborate with the Director, Data Integrity at the Allentown site to ensure alignment with corporate initiatives and the consistent implementation of Data Integrity standards, governance practices, risk assessment methodologies, training programs, and continuous improvement activities across the organization. The primary responsibilities of this role include site training on the requirements of ALCOA+, ensuring processes and procedures are in place to implement ALCOA+ principles in paper and computerized systems, ensuring that computerized system access controls, audit trail reviews and back-up and restore functions are appropriately implemented and meet cGMP requirements. The site Data Integrity Lead will also have responsibility for implementing and maintaining risk-based methodologies for the assessment and management of data integrity risks. The site Data Integrity Lead will drive a Data Integrity Management program across the Lee, MA manufacturing facility. This site-based role requires a strong leader with excellent communication skills and who is capable of prioritizing and managing multiple projects effectively. The successful candidate will be responsible for ensuring cGMP compliance as it pertains to Data Integrity Management across site operations and for implementing applicable corporate standards locally. Duties and Responsibilities Lead and maintain the site Data Integrity Management Program, including defining site objectives and scope, implementing corporate data integrity requirements, development and refinement of site procedures, implementing processes and metrics to monitor the effectiveness of the site Data Integrity program. Serve as the site Data Integrity subject matter expert (SME) during regulatory inspections and client audits, train/coach personnel on ALCOA+ principles and associated regulations and guidance documents. (e.g. GAMP5, PIC/S, 21 CFR Part 11, EudraLex Annex 11, FDA's Guidance for Industry, "Data Integrity and Compliance with Drug CGMP: Questions and Answers" (Final, 2018 . Report to the Site Quality Head and serve on the site Quality Leadership team and governance forums. Provide leadership and guidance to site functional representatives and system or process owners supporting Data Integrity objectives. Ensure site personnel understand and implement risk-based methodologies are understood and implemented as they pertain to data integrity management, especially when assessing legacy computerized systems, when validating new computerized systems and when evaluating proposed changes to existing computerized systems. Collaborate with the applicable corporate and site Data Governance, Quality, and Information Technology functions to integrate data integrity into the overall data governance framework, with particular emphasis on computerized systems and adherence to ALCOA+ principles. Collaborate cross-site to ensure that roles and responsibilities are clear regarding data management and stewardship of data integrity management. Provide guidance on the process to evaluate data integrity compliance through audits of Sharp and its suppliers. Lead or support site Data Integrity risk assessments, investigations, root cause analyses, corrective and preventive actions, and remediation plans. Ensure Data Integrity considerations are incorporated into computerized system validation, change control, incident management, periodic review, and system retirement activities. Review and trend site Data Integrity metrics, communicate program status and risks to site leadership, and drive continuous improvement and inspection readiness. Monitor relevant regulatory and industry expectations, assess site impact, and coordinate implementation of required site actions. Regulatory Responsibilities Conduct business in a responsible manner that complies with all state, OSHA, and HIPAA regulations Maintain a detailed and comprehensive understanding of FDA, EU, and other regulatory agency requirements as it pertains to data integrity. Supervisory Responsibilities This position has no direct reporting line responsibility; however, it will provide functional leadership and oversight to Data Integrity representatives and subject matter experts embedded within site operational units to support the execution of the Data Integrity Program. Experience Prefer a minimum of 5 years of experience in data management, data governance frameworks, and data quality tools, with a focus on computerized systems and adherence to ALCOA+ principles. Also prefer a minimum of at least 1.5 years in a leadership role within a pharmaceutical operation. Expertise in the application of 21 CFR Part 11, EudraLex Annex 11 and GAMP standards for data integrity and validation of automated systems is required. Proven experience of managing data integrity initiatives, particularly in relation to computerized systems, within a pharmaceutical organization. Experience collaborating cross functionally on investigations, CAPAs, risk assessments, and remediation programs associated with Data Integrity events or observations. Demonstrated history of influencing, motivating and effecting change with cross functional teams. Ability to independently determine and develop approaches to address simple to complex issues. Knowledge of and skill in using computer software and hardware applications. Excellent verbal and written communication/documentation skills with a demonstrated ability to clearly present technical topics to a non technical audience. Ability to influence and engage stakeholders at all levels. Excellent project management skills with the ability to manage multiple initiatives simultaneously. Strong analytical skills with the ability to interpret complex data sets from computerized systems and provide actionable insights. Experience of working in a sterile pharmaceutical manufacturing environment preferred. Education BS or higher degree in an IT, engineering, scientific discipline or other related field. A master's degree is a plus. Knowledge, Skills & Abilities Skilled in the use of Microsoft office applications (Word, Excel, PowerPoint) and Adobe Acrobat High attention to detail Good writing, public speaking and presentation skills Must be able to travel approximately 10% of the time Physical Requirements Ability to sit for prolonged periods of time Ability to stand for prolong periods of time as required Able to lift up to 10lbs
10/17/2026
Full time
Job Description Job Description Position Summary The Senior Manager, Data Integrity & Governance is responsible for leading and managing the Sharp Sterile Manufacturing site data integrity initiatives, with a focus on ensuring the accuracy, completeness, consistency, and reliability of GXP data across computerized and paper-based systems. The role will oversee the site's development, implementation, and monitoring of data integrity processes, policies, and tools that align with regulatory requirements, and enable adherence to ALCOA+ principles. The site Data Integrity Lead will work closely with the site functions including; IT, Manufacturing, Quality and Engineering to enable Data Integrity compliance using a Quality risk management approach. The site Data Integrity Lead will collaborate with the Director, Data Integrity at the Allentown site to ensure alignment with corporate initiatives and the consistent implementation of Data Integrity standards, governance practices, risk assessment methodologies, training programs, and continuous improvement activities across the organization. The primary responsibilities of this role include site training on the requirements of ALCOA+, ensuring processes and procedures are in place to implement ALCOA+ principles in paper and computerized systems, ensuring that computerized system access controls, audit trail reviews and back-up and restore functions are appropriately implemented and meet cGMP requirements. The site Data Integrity Lead will also have responsibility for implementing and maintaining risk-based methodologies for the assessment and management of data integrity risks. The site Data Integrity Lead will drive a Data Integrity Management program across the Lee, MA manufacturing facility. This site-based role requires a strong leader with excellent communication skills and who is capable of prioritizing and managing multiple projects effectively. The successful candidate will be responsible for ensuring cGMP compliance as it pertains to Data Integrity Management across site operations and for implementing applicable corporate standards locally. Duties and Responsibilities Lead and maintain the site Data Integrity Management Program, including defining site objectives and scope, implementing corporate data integrity requirements, development and refinement of site procedures, implementing processes and metrics to monitor the effectiveness of the site Data Integrity program. Serve as the site Data Integrity subject matter expert (SME) during regulatory inspections and client audits, train/coach personnel on ALCOA+ principles and associated regulations and guidance documents. (e.g. GAMP5, PIC/S, 21 CFR Part 11, EudraLex Annex 11, FDA's Guidance for Industry, "Data Integrity and Compliance with Drug CGMP: Questions and Answers" (Final, 2018 . Report to the Site Quality Head and serve on the site Quality Leadership team and governance forums. Provide leadership and guidance to site functional representatives and system or process owners supporting Data Integrity objectives. Ensure site personnel understand and implement risk-based methodologies are understood and implemented as they pertain to data integrity management, especially when assessing legacy computerized systems, when validating new computerized systems and when evaluating proposed changes to existing computerized systems. Collaborate with the applicable corporate and site Data Governance, Quality, and Information Technology functions to integrate data integrity into the overall data governance framework, with particular emphasis on computerized systems and adherence to ALCOA+ principles. Collaborate cross-site to ensure that roles and responsibilities are clear regarding data management and stewardship of data integrity management. Provide guidance on the process to evaluate data integrity compliance through audits of Sharp and its suppliers. Lead or support site Data Integrity risk assessments, investigations, root cause analyses, corrective and preventive actions, and remediation plans. Ensure Data Integrity considerations are incorporated into computerized system validation, change control, incident management, periodic review, and system retirement activities. Review and trend site Data Integrity metrics, communicate program status and risks to site leadership, and drive continuous improvement and inspection readiness. Monitor relevant regulatory and industry expectations, assess site impact, and coordinate implementation of required site actions. Regulatory Responsibilities Conduct business in a responsible manner that complies with all state, OSHA, and HIPAA regulations Maintain a detailed and comprehensive understanding of FDA, EU, and other regulatory agency requirements as it pertains to data integrity. Supervisory Responsibilities This position has no direct reporting line responsibility; however, it will provide functional leadership and oversight to Data Integrity representatives and subject matter experts embedded within site operational units to support the execution of the Data Integrity Program. Experience Prefer a minimum of 5 years of experience in data management, data governance frameworks, and data quality tools, with a focus on computerized systems and adherence to ALCOA+ principles. Also prefer a minimum of at least 1.5 years in a leadership role within a pharmaceutical operation. Expertise in the application of 21 CFR Part 11, EudraLex Annex 11 and GAMP standards for data integrity and validation of automated systems is required. Proven experience of managing data integrity initiatives, particularly in relation to computerized systems, within a pharmaceutical organization. Experience collaborating cross functionally on investigations, CAPAs, risk assessments, and remediation programs associated with Data Integrity events or observations. Demonstrated history of influencing, motivating and effecting change with cross functional teams. Ability to independently determine and develop approaches to address simple to complex issues. Knowledge of and skill in using computer software and hardware applications. Excellent verbal and written communication/documentation skills with a demonstrated ability to clearly present technical topics to a non technical audience. Ability to influence and engage stakeholders at all levels. Excellent project management skills with the ability to manage multiple initiatives simultaneously. Strong analytical skills with the ability to interpret complex data sets from computerized systems and provide actionable insights. Experience of working in a sterile pharmaceutical manufacturing environment preferred. Education BS or higher degree in an IT, engineering, scientific discipline or other related field. A master's degree is a plus. Knowledge, Skills & Abilities Skilled in the use of Microsoft office applications (Word, Excel, PowerPoint) and Adobe Acrobat High attention to detail Good writing, public speaking and presentation skills Must be able to travel approximately 10% of the time Physical Requirements Ability to sit for prolonged periods of time Ability to stand for prolong periods of time as required Able to lift up to 10lbs
Job Description Job Description Position Summary The Senior Manager, Data Integrity & Governance is responsible for leading and managing the Sharp Sterile Manufacturing site data integrity initiatives, with a focus on ensuring the accuracy, completeness, consistency, and reliability of GXP data across computerized and paper-based systems. The role will oversee the site's development, implementation, and monitoring of data integrity processes, policies, and tools that align with regulatory requirements, and enable adherence to ALCOA+ principles. The site Data Integrity Lead will work closely with the site functions including; IT, Manufacturing, Quality and Engineering to enable Data Integrity compliance using a Quality risk management approach. The site Data Integrity Lead will collaborate with the Director, Data Integrity at the Allentown site to ensure alignment with corporate initiatives and the consistent implementation of Data Integrity standards, governance practices, risk assessment methodologies, training programs, and continuous improvement activities across the organization. The primary responsibilities of this role include site training on the requirements of ALCOA+, ensuring processes and procedures are in place to implement ALCOA+ principles in paper and computerized systems, ensuring that computerized system access controls, audit trail reviews and back-up and restore functions are appropriately implemented and meet cGMP requirements. The site Data Integrity Lead will also have responsibility for implementing and maintaining risk-based methodologies for the assessment and management of data integrity risks. The site Data Integrity Lead will drive a Data Integrity Management program across the Lee, MA manufacturing facility. This site-based role requires a strong leader with excellent communication skills and who is capable of prioritizing and managing multiple projects effectively. The successful candidate will be responsible for ensuring cGMP compliance as it pertains to Data Integrity Management across site operations and for implementing applicable corporate standards locally. Duties and Responsibilities Lead and maintain the site Data Integrity Management Program, including defining site objectives and scope, implementing corporate data integrity requirements, development and refinement of site procedures, implementing processes and metrics to monitor the effectiveness of the site Data Integrity program. Serve as the site Data Integrity subject matter expert (SME) during regulatory inspections and client audits, train/coach personnel on ALCOA+ principles and associated regulations and guidance documents. (e.g. GAMP5, PIC/S, 21 CFR Part 11, EudraLex Annex 11, FDA's Guidance for Industry, "Data Integrity and Compliance with Drug CGMP: Questions and Answers" (Final, 2018 . Report to the Site Quality Head and serve on the site Quality Leadership team and governance forums. Provide leadership and guidance to site functional representatives and system or process owners supporting Data Integrity objectives. Ensure site personnel understand and implement risk-based methodologies are understood and implemented as they pertain to data integrity management, especially when assessing legacy computerized systems, when validating new computerized systems and when evaluating proposed changes to existing computerized systems. Collaborate with the applicable corporate and site Data Governance, Quality, and Information Technology functions to integrate data integrity into the overall data governance framework, with particular emphasis on computerized systems and adherence to ALCOA+ principles. Collaborate cross-site to ensure that roles and responsibilities are clear regarding data management and stewardship of data integrity management. Provide guidance on the process to evaluate data integrity compliance through audits of Sharp and its suppliers. Lead or support site Data Integrity risk assessments, investigations, root cause analyses, corrective and preventive actions, and remediation plans. Ensure Data Integrity considerations are incorporated into computerized system validation, change control, incident management, periodic review, and system retirement activities. Review and trend site Data Integrity metrics, communicate program status and risks to site leadership, and drive continuous improvement and inspection readiness. Monitor relevant regulatory and industry expectations, assess site impact, and coordinate implementation of required site actions. Regulatory Responsibilities Conduct business in a responsible manner that complies with all state, OSHA, and HIPAA regulations Maintain a detailed and comprehensive understanding of FDA, EU, and other regulatory agency requirements as it pertains to data integrity. Supervisory Responsibilities This position has no direct reporting line responsibility; however, it will provide functional leadership and oversight to Data Integrity representatives and subject matter experts embedded within site operational units to support the execution of the Data Integrity Program. Experience Prefer a minimum of 5 years of experience in data management, data governance frameworks, and data quality tools, with a focus on computerized systems and adherence to ALCOA+ principles. Also prefer a minimum of at least 1.5 years in a leadership role within a pharmaceutical operation. Expertise in the application of 21 CFR Part 11, EudraLex Annex 11 and GAMP standards for data integrity and validation of automated systems is required. Proven experience of managing data integrity initiatives, particularly in relation to computerized systems, within a pharmaceutical organization. Experience collaborating cross functionally on investigations, CAPAs, risk assessments, and remediation programs associated with Data Integrity events or observations. Demonstrated history of influencing, motivating and effecting change with cross functional teams. Ability to independently determine and develop approaches to address simple to complex issues. Knowledge of and skill in using computer software and hardware applications. Excellent verbal and written communication/documentation skills with a demonstrated ability to clearly present technical topics to a non technical audience. Ability to influence and engage stakeholders at all levels. Excellent project management skills with the ability to manage multiple initiatives simultaneously. Strong analytical skills with the ability to interpret complex data sets from computerized systems and provide actionable insights. Experience of working in a sterile pharmaceutical manufacturing environment preferred. Education BS or higher degree in an IT, engineering, scientific discipline or other related field. A master's degree is a plus. Knowledge, Skills & Abilities Skilled in the use of Microsoft office applications (Word, Excel, PowerPoint) and Adobe Acrobat High attention to detail Good writing, public speaking and presentation skills Must be able to travel approximately 10% of the time Physical Requirements Ability to sit for prolonged periods of time Ability to stand for prolong periods of time as required Able to lift up to 10lbs
09/30/2026
Full time
Job Description Job Description Position Summary The Senior Manager, Data Integrity & Governance is responsible for leading and managing the Sharp Sterile Manufacturing site data integrity initiatives, with a focus on ensuring the accuracy, completeness, consistency, and reliability of GXP data across computerized and paper-based systems. The role will oversee the site's development, implementation, and monitoring of data integrity processes, policies, and tools that align with regulatory requirements, and enable adherence to ALCOA+ principles. The site Data Integrity Lead will work closely with the site functions including; IT, Manufacturing, Quality and Engineering to enable Data Integrity compliance using a Quality risk management approach. The site Data Integrity Lead will collaborate with the Director, Data Integrity at the Allentown site to ensure alignment with corporate initiatives and the consistent implementation of Data Integrity standards, governance practices, risk assessment methodologies, training programs, and continuous improvement activities across the organization. The primary responsibilities of this role include site training on the requirements of ALCOA+, ensuring processes and procedures are in place to implement ALCOA+ principles in paper and computerized systems, ensuring that computerized system access controls, audit trail reviews and back-up and restore functions are appropriately implemented and meet cGMP requirements. The site Data Integrity Lead will also have responsibility for implementing and maintaining risk-based methodologies for the assessment and management of data integrity risks. The site Data Integrity Lead will drive a Data Integrity Management program across the Lee, MA manufacturing facility. This site-based role requires a strong leader with excellent communication skills and who is capable of prioritizing and managing multiple projects effectively. The successful candidate will be responsible for ensuring cGMP compliance as it pertains to Data Integrity Management across site operations and for implementing applicable corporate standards locally. Duties and Responsibilities Lead and maintain the site Data Integrity Management Program, including defining site objectives and scope, implementing corporate data integrity requirements, development and refinement of site procedures, implementing processes and metrics to monitor the effectiveness of the site Data Integrity program. Serve as the site Data Integrity subject matter expert (SME) during regulatory inspections and client audits, train/coach personnel on ALCOA+ principles and associated regulations and guidance documents. (e.g. GAMP5, PIC/S, 21 CFR Part 11, EudraLex Annex 11, FDA's Guidance for Industry, "Data Integrity and Compliance with Drug CGMP: Questions and Answers" (Final, 2018 . Report to the Site Quality Head and serve on the site Quality Leadership team and governance forums. Provide leadership and guidance to site functional representatives and system or process owners supporting Data Integrity objectives. Ensure site personnel understand and implement risk-based methodologies are understood and implemented as they pertain to data integrity management, especially when assessing legacy computerized systems, when validating new computerized systems and when evaluating proposed changes to existing computerized systems. Collaborate with the applicable corporate and site Data Governance, Quality, and Information Technology functions to integrate data integrity into the overall data governance framework, with particular emphasis on computerized systems and adherence to ALCOA+ principles. Collaborate cross-site to ensure that roles and responsibilities are clear regarding data management and stewardship of data integrity management. Provide guidance on the process to evaluate data integrity compliance through audits of Sharp and its suppliers. Lead or support site Data Integrity risk assessments, investigations, root cause analyses, corrective and preventive actions, and remediation plans. Ensure Data Integrity considerations are incorporated into computerized system validation, change control, incident management, periodic review, and system retirement activities. Review and trend site Data Integrity metrics, communicate program status and risks to site leadership, and drive continuous improvement and inspection readiness. Monitor relevant regulatory and industry expectations, assess site impact, and coordinate implementation of required site actions. Regulatory Responsibilities Conduct business in a responsible manner that complies with all state, OSHA, and HIPAA regulations Maintain a detailed and comprehensive understanding of FDA, EU, and other regulatory agency requirements as it pertains to data integrity. Supervisory Responsibilities This position has no direct reporting line responsibility; however, it will provide functional leadership and oversight to Data Integrity representatives and subject matter experts embedded within site operational units to support the execution of the Data Integrity Program. Experience Prefer a minimum of 5 years of experience in data management, data governance frameworks, and data quality tools, with a focus on computerized systems and adherence to ALCOA+ principles. Also prefer a minimum of at least 1.5 years in a leadership role within a pharmaceutical operation. Expertise in the application of 21 CFR Part 11, EudraLex Annex 11 and GAMP standards for data integrity and validation of automated systems is required. Proven experience of managing data integrity initiatives, particularly in relation to computerized systems, within a pharmaceutical organization. Experience collaborating cross functionally on investigations, CAPAs, risk assessments, and remediation programs associated with Data Integrity events or observations. Demonstrated history of influencing, motivating and effecting change with cross functional teams. Ability to independently determine and develop approaches to address simple to complex issues. Knowledge of and skill in using computer software and hardware applications. Excellent verbal and written communication/documentation skills with a demonstrated ability to clearly present technical topics to a non technical audience. Ability to influence and engage stakeholders at all levels. Excellent project management skills with the ability to manage multiple initiatives simultaneously. Strong analytical skills with the ability to interpret complex data sets from computerized systems and provide actionable insights. Experience of working in a sterile pharmaceutical manufacturing environment preferred. Education BS or higher degree in an IT, engineering, scientific discipline or other related field. A master's degree is a plus. Knowledge, Skills & Abilities Skilled in the use of Microsoft office applications (Word, Excel, PowerPoint) and Adobe Acrobat High attention to detail Good writing, public speaking and presentation skills Must be able to travel approximately 10% of the time Physical Requirements Ability to sit for prolonged periods of time Ability to stand for prolong periods of time as required Able to lift up to 10lbs
Job Description Job Description Company Description Big challenges need bold thinkers. If you're someone who sees problems as opportunities, you'll thrive here. RESPEC is 100% employee-owned , which means we take ownership of every challenge. Here, your ideas drive real solutions. Since 1969, we've tackled complex challenges in energy transition, infrastructure resilience, digital transformation, and sustainability. At RESPEC, you'll work alongside clients to take on critical problems . Depending on your expertise, you might design infrastructure in remote locations, develop renewable energy solutions for global projects, or apply data-driven technology to improve mining and water systems. We bring deep technical knowledge, real-world experience, and a commitment to work that matters. If you're looking for a place where your contributions have real impact, you'll fit right in. We do not accept unsolicited resumes from third-party recruiters. Job Description RESPEC is seeking a Configuration Manager to lead configuration management activities for complex enterprise engineering systems, software applications, hardware/software integrated environments, and Digital Thread modernization initiatives. This position establishes and administers Configuration Management Plans (CMPs), configuration baselines, change-control processes, traceability practices, release-management controls, and audit-ready documentation. The Configuration Manager works with engineering stakeholders, project managers, system architects, software developers, quality assurance personnel, cybersecurity personnel, business/process engineers, and operations and maintenance teams to ensure that approved changes are documented, reviewed, controlled, tested, released, and maintained in accordance with applicable requirements. The role supports disciplined configuration control across PLM, CAD, ALM, DevOps, and enterprise software environments. Hands-on software development or CAD drafting is not required. The successful candidate will demonstrate the ability to manage configuration management processes for complex enterprise applications and engineering environments. Key Responsibilities Establish, maintain, and execute Configuration Management Plans (CMPs) for enterprise engineering systems, software applications, integrations, interfaces, and related technical environments. Lead Change Control Boards (CCBs), including the preparation, coordination, tracking, documentation, and follow-up of proposed changes, decisions, approvals, and action items. Establish and maintain configuration baselines for software, hardware, engineering data, system documentation, interfaces, releases, and operational environments. Enforce traceability across software or hardware life cycles and maintain audit readiness for complex enterprise applications. Coordinate configuration management activities across PLM, CAD data-management, ALM, DevOps, software-development, quality assurance, systems integration, and operations and maintenance efforts. Review, document, track, and maintain records for configuration items, version histories, change requests, approvals, release packages, baseline updates, and configuration-status accounting. Support the planning and execution of software upgrades, system integrations, releases, deployments, cutovers, and post-deployment validation activities. Ensure configuration-controlled artifacts are appropriately identified, versioned, reviewed, approved, stored, and available to authorized stakeholders. Support release-management and deployment-readiness activities by confirming that changes have completed required review, testing, documentation, approval, and baseline-management processes. Work with quality assurance and test personnel to ensure that configuration changes are traceable to applicable requirements, test plans, test results, defects, and resolution records. Support the maintenance of configuration documentation, including CMPs, configuration-item inventories, baseline records, change logs, release records, CCB materials, and audit-support artifacts. Identify configuration-management risks, control gaps, documentation deficiencies, and process-improvement opportunities; communicate findings and support corrective actions. Coordinate with project managers and technical leads to align configuration-management activities with task-order schedules, milestones, deliverables, and implementation plans. Support governance and compliance activities in environments requiring formal change control, controlled releases, security awareness, and structured documentation. Assist with knowledge-transfer activities related to configuration-management procedures, configuration-control processes, change-management requirements, and release-management practices. Qualifications Required Qualifications & Experience Education & Years of Experience: Bachelor's degree in CS, Information Systems, Engineering, or a related field; 5-10 years (Senior) or 10-15 years (Principal) of dedicated Configuration Management experience. CM certifications (e.g., CMPIC, ITIL, NDIA) are a strong plus. Domain Exposure (Must meet AT LEAST ONE of the following): DOE / National Labs: Direct experience within the Department of Energy (DOE), NNSA, or National Laboratories (e.g., Sandia, Los Alamos, Lawrence Livermore, Oak Ridge, Idaho National Lab). Broader Federal / Defense / Aerospace: Experience within complex DoD branches (Army, Navy, Air Force, Space Force), NASA, DHS, DOT, or major defense prime contractors. Strictly Regulated Commercial Industries: Experience managing configuration in heavily audited, highly regulated sectors such as commercial nuclear power, medical devices (FDA-regulated), automotive (ISO 26262), semiconductor manufacturing, or commercial aviation (FAA-regulated). Technical/Tooling Context (Must meet AT LEAST ONE of the following): PTC Ecosystem: Experience supporting environments using PTC products (Windchill, PDMLink, CodeBeamer, Creo). Alternative Enterprise PLM / CAD Suites: Experience managing CM baselines for other major PLM or CAD data management platforms, such as Siemens Teamcenter, Dassault Systèmes (Enovia, 3DEXPERIENCE, SolidWorks PDM), Autodesk Fusion Lifecycle/Vault, or Aras Innovator. Enterprise Software / ALM / DevOps Pipelines: Experience establishing CM controls using mainstream Application Lifecycle Management (ALM) or DevOps toolchains, such as Azure DevOps, Jira/Confluence, Git, GitLab, Jenkins, ServiceNow, or IBM Rational/DOORS. Core Competency: Proven ability to lead Change Control Boards (CCBs), establish Configuration Management Plans (CMPs), enforce traceability across software or hardware life cycles, and maintain audit readiness for complex enterprise applications. Hands-on software development or CAD drafting is not required. Demonstrated ability to coordinate configuration-management activities across multiple technical teams, systems, interfaces, and controlled-release activities. Demonstrated ability to produce clear, complete, and accurate configuration-management documentation, change-control records, baseline records, and audit-support materials. Ability to communicate configuration-management requirements, status, risks, and decisions effectively to technical and non-technical stakeholders. Additional Information All your information will be kept confidential according to EEO guidelines. All your information will be kept confidential according to EEO guidelines.
09/26/2026
Full time
Job Description Job Description Company Description Big challenges need bold thinkers. If you're someone who sees problems as opportunities, you'll thrive here. RESPEC is 100% employee-owned , which means we take ownership of every challenge. Here, your ideas drive real solutions. Since 1969, we've tackled complex challenges in energy transition, infrastructure resilience, digital transformation, and sustainability. At RESPEC, you'll work alongside clients to take on critical problems . Depending on your expertise, you might design infrastructure in remote locations, develop renewable energy solutions for global projects, or apply data-driven technology to improve mining and water systems. We bring deep technical knowledge, real-world experience, and a commitment to work that matters. If you're looking for a place where your contributions have real impact, you'll fit right in. We do not accept unsolicited resumes from third-party recruiters. Job Description RESPEC is seeking a Configuration Manager to lead configuration management activities for complex enterprise engineering systems, software applications, hardware/software integrated environments, and Digital Thread modernization initiatives. This position establishes and administers Configuration Management Plans (CMPs), configuration baselines, change-control processes, traceability practices, release-management controls, and audit-ready documentation. The Configuration Manager works with engineering stakeholders, project managers, system architects, software developers, quality assurance personnel, cybersecurity personnel, business/process engineers, and operations and maintenance teams to ensure that approved changes are documented, reviewed, controlled, tested, released, and maintained in accordance with applicable requirements. The role supports disciplined configuration control across PLM, CAD, ALM, DevOps, and enterprise software environments. Hands-on software development or CAD drafting is not required. The successful candidate will demonstrate the ability to manage configuration management processes for complex enterprise applications and engineering environments. Key Responsibilities Establish, maintain, and execute Configuration Management Plans (CMPs) for enterprise engineering systems, software applications, integrations, interfaces, and related technical environments. Lead Change Control Boards (CCBs), including the preparation, coordination, tracking, documentation, and follow-up of proposed changes, decisions, approvals, and action items. Establish and maintain configuration baselines for software, hardware, engineering data, system documentation, interfaces, releases, and operational environments. Enforce traceability across software or hardware life cycles and maintain audit readiness for complex enterprise applications. Coordinate configuration management activities across PLM, CAD data-management, ALM, DevOps, software-development, quality assurance, systems integration, and operations and maintenance efforts. Review, document, track, and maintain records for configuration items, version histories, change requests, approvals, release packages, baseline updates, and configuration-status accounting. Support the planning and execution of software upgrades, system integrations, releases, deployments, cutovers, and post-deployment validation activities. Ensure configuration-controlled artifacts are appropriately identified, versioned, reviewed, approved, stored, and available to authorized stakeholders. Support release-management and deployment-readiness activities by confirming that changes have completed required review, testing, documentation, approval, and baseline-management processes. Work with quality assurance and test personnel to ensure that configuration changes are traceable to applicable requirements, test plans, test results, defects, and resolution records. Support the maintenance of configuration documentation, including CMPs, configuration-item inventories, baseline records, change logs, release records, CCB materials, and audit-support artifacts. Identify configuration-management risks, control gaps, documentation deficiencies, and process-improvement opportunities; communicate findings and support corrective actions. Coordinate with project managers and technical leads to align configuration-management activities with task-order schedules, milestones, deliverables, and implementation plans. Support governance and compliance activities in environments requiring formal change control, controlled releases, security awareness, and structured documentation. Assist with knowledge-transfer activities related to configuration-management procedures, configuration-control processes, change-management requirements, and release-management practices. Qualifications Required Qualifications & Experience Education & Years of Experience: Bachelor's degree in CS, Information Systems, Engineering, or a related field; 5-10 years (Senior) or 10-15 years (Principal) of dedicated Configuration Management experience. CM certifications (e.g., CMPIC, ITIL, NDIA) are a strong plus. Domain Exposure (Must meet AT LEAST ONE of the following): DOE / National Labs: Direct experience within the Department of Energy (DOE), NNSA, or National Laboratories (e.g., Sandia, Los Alamos, Lawrence Livermore, Oak Ridge, Idaho National Lab). Broader Federal / Defense / Aerospace: Experience within complex DoD branches (Army, Navy, Air Force, Space Force), NASA, DHS, DOT, or major defense prime contractors. Strictly Regulated Commercial Industries: Experience managing configuration in heavily audited, highly regulated sectors such as commercial nuclear power, medical devices (FDA-regulated), automotive (ISO 26262), semiconductor manufacturing, or commercial aviation (FAA-regulated). Technical/Tooling Context (Must meet AT LEAST ONE of the following): PTC Ecosystem: Experience supporting environments using PTC products (Windchill, PDMLink, CodeBeamer, Creo). Alternative Enterprise PLM / CAD Suites: Experience managing CM baselines for other major PLM or CAD data management platforms, such as Siemens Teamcenter, Dassault Systèmes (Enovia, 3DEXPERIENCE, SolidWorks PDM), Autodesk Fusion Lifecycle/Vault, or Aras Innovator. Enterprise Software / ALM / DevOps Pipelines: Experience establishing CM controls using mainstream Application Lifecycle Management (ALM) or DevOps toolchains, such as Azure DevOps, Jira/Confluence, Git, GitLab, Jenkins, ServiceNow, or IBM Rational/DOORS. Core Competency: Proven ability to lead Change Control Boards (CCBs), establish Configuration Management Plans (CMPs), enforce traceability across software or hardware life cycles, and maintain audit readiness for complex enterprise applications. Hands-on software development or CAD drafting is not required. Demonstrated ability to coordinate configuration-management activities across multiple technical teams, systems, interfaces, and controlled-release activities. Demonstrated ability to produce clear, complete, and accurate configuration-management documentation, change-control records, baseline records, and audit-support materials. Ability to communicate configuration-management requirements, status, risks, and decisions effectively to technical and non-technical stakeholders. Additional Information All your information will be kept confidential according to EEO guidelines. All your information will be kept confidential according to EEO guidelines.
Job Description Job Description Job Summary: The Senior Technical Lead at Urban Farmer is responsible for leading and supporting technical systems, infrastructure, and digital solutions that enable efficient, safe, and compliant food manufacturing operations. This role provides technical leadership across manufacturing, quality, maintenance, and business systems, ensuring technology solutions align with Urban Farmer's operational goals, food safety standards, and continuous improvement initiatives. The Senior Technical Lead serves as a hands-on technical expert and mentor, partnering closely with Operations, Maintenance, Quality, Supply Chain, and Leadership teams to deliver reliable, scalable, and secure technical solutions that support plant performance and business growth. Schedule : This position may require up to six (6) days of work per week based on business needs and operational demands. Key Responsibilities: Technical Leadership & Systems Oversight Lead the design, implementation, and support of scalable and reliable technical solutions across manufacturing and enterprise systems. Serve as the primary technical authority for system architecture, integrations, and troubleshooting across production, quality, and operational platforms. Establish and enforce technical standards, best practices, and documentation for system configuration, development, testing, and deployment. Support and maintain critical plant systems to ensure uptime, performance, and data integrity in a manufacturing environment. Manufacturing & Operations Support Partner with Operations, Maintenance, and Quality teams to support technology that enables production efficiency, food safety, traceability, and compliance. Assist with technical support for manufacturing systems, equipment interfaces, data collection, and reporting tools. Identify opportunities to improve system reliability, automation, and data visibility across bakery, toppings, warehouse, and logistics functions. Project Execution & Delivery Collaborate with project managers and cross-functional leaders to define technical scope, requirements, timelines, and resource needs for plant and corporate initiatives. Translate business and operational requirements into practical, well-designed technical solutions. Manage technical risks, dependencies, and change impacts to ensure projects are delivered on time and within scope. Team Leadership, Collaboration & Mentorship Lead, mentor, and support technical team members, fostering a culture of accountability, continuous learning, and problem-solving. Provide hands-on guidance, coaching, and feedback to improve technical skills, documentation, and execution. Facilitate technical reviews, knowledge sharing, and post-project evaluations to drive continuous improvement. Stakeholder Engagement & Communication Act as a key liaison between technical teams and Operations, Quality, Maintenance, Supply Chain, and Leadership. Clearly communicate technical concepts, system impacts, risks, and recommendations to both technical and non-technical stakeholders. Support leadership decision-making by providing clear technical insight and data-driven recommendations. Innovation, Optimization & Continuous Improvement Evaluate and recommend new technologies, tools, and systems that support operational efficiency, scalability, and cost control. Lead initiatives to modernize legacy systems and optimize existing platforms to improve performance, reliability, and user experience. Support Urban Farmer's continuous improvement mindset through technology-enabled process enhancements. Quality, Security & Compliance Ensure systems support food safety, quality, and regulatory requirements (GMPs, SQF, traceability, and audit readiness). Implement appropriate testing, monitoring, and security measures to protect systems and data. Support incident response, root cause analysis, and corrective actions related to system failures or performance issues. Qualifications: Education and Experience: Bachelor's or Master's degree in Computer Science, Information Technology, or a related field. 7+ years of experience in software development, systems architecture, or technical leadership roles. Technical Skills: Proficiency in programming languages such as Python, Java, or C#. Expertise in system design, cloud platforms (e.g., AWS, Azure, Google Cloud), and DevOps tools. Strong understanding of databases, APIs, and microservices architecture. Leadership Skills: Proven experience in leading diverse technical teams. Strong problem-solving abilities and decision-making skills. Soft Skills: Excellent communication and interpersonal skills. Ability to adapt to fast-paced environments and manage multiple priorities effectively. 1st Shift
09/26/2026
Full time
Job Description Job Description Job Summary: The Senior Technical Lead at Urban Farmer is responsible for leading and supporting technical systems, infrastructure, and digital solutions that enable efficient, safe, and compliant food manufacturing operations. This role provides technical leadership across manufacturing, quality, maintenance, and business systems, ensuring technology solutions align with Urban Farmer's operational goals, food safety standards, and continuous improvement initiatives. The Senior Technical Lead serves as a hands-on technical expert and mentor, partnering closely with Operations, Maintenance, Quality, Supply Chain, and Leadership teams to deliver reliable, scalable, and secure technical solutions that support plant performance and business growth. Schedule : This position may require up to six (6) days of work per week based on business needs and operational demands. Key Responsibilities: Technical Leadership & Systems Oversight Lead the design, implementation, and support of scalable and reliable technical solutions across manufacturing and enterprise systems. Serve as the primary technical authority for system architecture, integrations, and troubleshooting across production, quality, and operational platforms. Establish and enforce technical standards, best practices, and documentation for system configuration, development, testing, and deployment. Support and maintain critical plant systems to ensure uptime, performance, and data integrity in a manufacturing environment. Manufacturing & Operations Support Partner with Operations, Maintenance, and Quality teams to support technology that enables production efficiency, food safety, traceability, and compliance. Assist with technical support for manufacturing systems, equipment interfaces, data collection, and reporting tools. Identify opportunities to improve system reliability, automation, and data visibility across bakery, toppings, warehouse, and logistics functions. Project Execution & Delivery Collaborate with project managers and cross-functional leaders to define technical scope, requirements, timelines, and resource needs for plant and corporate initiatives. Translate business and operational requirements into practical, well-designed technical solutions. Manage technical risks, dependencies, and change impacts to ensure projects are delivered on time and within scope. Team Leadership, Collaboration & Mentorship Lead, mentor, and support technical team members, fostering a culture of accountability, continuous learning, and problem-solving. Provide hands-on guidance, coaching, and feedback to improve technical skills, documentation, and execution. Facilitate technical reviews, knowledge sharing, and post-project evaluations to drive continuous improvement. Stakeholder Engagement & Communication Act as a key liaison between technical teams and Operations, Quality, Maintenance, Supply Chain, and Leadership. Clearly communicate technical concepts, system impacts, risks, and recommendations to both technical and non-technical stakeholders. Support leadership decision-making by providing clear technical insight and data-driven recommendations. Innovation, Optimization & Continuous Improvement Evaluate and recommend new technologies, tools, and systems that support operational efficiency, scalability, and cost control. Lead initiatives to modernize legacy systems and optimize existing platforms to improve performance, reliability, and user experience. Support Urban Farmer's continuous improvement mindset through technology-enabled process enhancements. Quality, Security & Compliance Ensure systems support food safety, quality, and regulatory requirements (GMPs, SQF, traceability, and audit readiness). Implement appropriate testing, monitoring, and security measures to protect systems and data. Support incident response, root cause analysis, and corrective actions related to system failures or performance issues. Qualifications: Education and Experience: Bachelor's or Master's degree in Computer Science, Information Technology, or a related field. 7+ years of experience in software development, systems architecture, or technical leadership roles. Technical Skills: Proficiency in programming languages such as Python, Java, or C#. Expertise in system design, cloud platforms (e.g., AWS, Azure, Google Cloud), and DevOps tools. Strong understanding of databases, APIs, and microservices architecture. Leadership Skills: Proven experience in leading diverse technical teams. Strong problem-solving abilities and decision-making skills. Soft Skills: Excellent communication and interpersonal skills. Ability to adapt to fast-paced environments and manage multiple priorities effectively. 1st Shift
Job Description Job Description Position Summary The Senior Manager, Data Integrity & Governance is responsible for leading and managing the Sharp Sterile Manufacturing site data integrity initiatives, with a focus on ensuring the accuracy, completeness, consistency, and reliability of GXP data across computerized and paper-based systems. The role will oversee the site's development, implementation, and monitoring of data integrity processes, policies, and tools that align with regulatory requirements, and enable adherence to ALCOA+ principles. The site Data Integrity Lead will work closely with the site functions including; IT, Manufacturing, Quality and Engineering to enable Data Integrity compliance using a Quality risk management approach. The site Data Integrity Lead will collaborate with the Director, Data Integrity at the Allentown site to ensure alignment with corporate initiatives and the consistent implementation of Data Integrity standards, governance practices, risk assessment methodologies, training programs, and continuous improvement activities across the organization. The primary responsibilities of this role include site training on the requirements of ALCOA+, ensuring processes and procedures are in place to implement ALCOA+ principles in paper and computerized systems, ensuring that computerized system access controls, audit trail reviews and back-up and restore functions are appropriately implemented and meet cGMP requirements. The site Data Integrity Lead will also have responsibility for implementing and maintaining risk-based methodologies for the assessment and management of data integrity risks. The site Data Integrity Lead will drive a Data Integrity Management program across the Lee, MA manufacturing facility. This site-based role requires a strong leader with excellent communication skills and who is capable of prioritizing and managing multiple projects effectively. The successful candidate will be responsible for ensuring cGMP compliance as it pertains to Data Integrity Management across site operations and for implementing applicable corporate standards locally. Duties and Responsibilities Lead and maintain the site Data Integrity Management Program, including defining site objectives and scope, implementing corporate data integrity requirements, development and refinement of site procedures, implementing processes and metrics to monitor the effectiveness of the site Data Integrity program. Serve as the site Data Integrity subject matter expert (SME) during regulatory inspections and client audits, train/coach personnel on ALCOA+ principles and associated regulations and guidance documents. (e.g. GAMP5, PIC/S, 21 CFR Part 11, EudraLex Annex 11, FDA's Guidance for Industry, "Data Integrity and Compliance with Drug CGMP: Questions and Answers" (Final, 2018 . Report to the Site Quality Head and serve on the site Quality Leadership team and governance forums. Provide leadership and guidance to site functional representatives and system or process owners supporting Data Integrity objectives. Ensure site personnel understand and implement risk-based methodologies are understood and implemented as they pertain to data integrity management, especially when assessing legacy computerized systems, when validating new computerized systems and when evaluating proposed changes to existing computerized systems. Collaborate with the applicable corporate and site Data Governance, Quality, and Information Technology functions to integrate data integrity into the overall data governance framework, with particular emphasis on computerized systems and adherence to ALCOA+ principles. Collaborate cross-site to ensure that roles and responsibilities are clear regarding data management and stewardship of data integrity management. Provide guidance on the process to evaluate data integrity compliance through audits of Sharp and its suppliers. Lead or support site Data Integrity risk assessments, investigations, root cause analyses, corrective and preventive actions, and remediation plans. Ensure Data Integrity considerations are incorporated into computerized system validation, change control, incident management, periodic review, and system retirement activities. Review and trend site Data Integrity metrics, communicate program status and risks to site leadership, and drive continuous improvement and inspection readiness. Monitor relevant regulatory and industry expectations, assess site impact, and coordinate implementation of required site actions. Regulatory Responsibilities Conduct business in a responsible manner that complies with all state, OSHA, and HIPAA regulations Maintain a detailed and comprehensive understanding of FDA, EU, and other regulatory agency requirements as it pertains to data integrity. Supervisory Responsibilities This position has no direct reporting line responsibility; however, it will provide functional leadership and oversight to Data Integrity representatives and subject matter experts embedded within site operational units to support the execution of the Data Integrity Program. Experience Prefer a minimum of 5 years of experience in data management, data governance frameworks, and data quality tools, with a focus on computerized systems and adherence to ALCOA+ principles. Also prefer a minimum of at least 1.5 years in a leadership role within a pharmaceutical operation. Expertise in the application of 21 CFR Part 11, EudraLex Annex 11 and GAMP standards for data integrity and validation of automated systems is required. Proven experience of managing data integrity initiatives, particularly in relation to computerized systems, within a pharmaceutical organization. Experience collaborating cross functionally on investigations, CAPAs, risk assessments, and remediation programs associated with Data Integrity events or observations. Demonstrated history of influencing, motivating and effecting change with cross functional teams. Ability to independently determine and develop approaches to address simple to complex issues. Knowledge of and skill in using computer software and hardware applications. Excellent verbal and written communication/documentation skills with a demonstrated ability to clearly present technical topics to a non technical audience. Ability to influence and engage stakeholders at all levels. Excellent project management skills with the ability to manage multiple initiatives simultaneously. Strong analytical skills with the ability to interpret complex data sets from computerized systems and provide actionable insights. Experience of working in a sterile pharmaceutical manufacturing environment preferred. Education BS or higher degree in an IT, engineering, scientific discipline or other related field. A master's degree is a plus. Knowledge, Skills & Abilities Skilled in the use of Microsoft office applications (Word, Excel, PowerPoint) and Adobe Acrobat High attention to detail Good writing, public speaking and presentation skills Must be able to travel approximately 10% of the time Physical Requirements Ability to sit for prolonged periods of time Ability to stand for prolong periods of time as required Able to lift up to 10lbs
09/09/2026
Full time
Job Description Job Description Position Summary The Senior Manager, Data Integrity & Governance is responsible for leading and managing the Sharp Sterile Manufacturing site data integrity initiatives, with a focus on ensuring the accuracy, completeness, consistency, and reliability of GXP data across computerized and paper-based systems. The role will oversee the site's development, implementation, and monitoring of data integrity processes, policies, and tools that align with regulatory requirements, and enable adherence to ALCOA+ principles. The site Data Integrity Lead will work closely with the site functions including; IT, Manufacturing, Quality and Engineering to enable Data Integrity compliance using a Quality risk management approach. The site Data Integrity Lead will collaborate with the Director, Data Integrity at the Allentown site to ensure alignment with corporate initiatives and the consistent implementation of Data Integrity standards, governance practices, risk assessment methodologies, training programs, and continuous improvement activities across the organization. The primary responsibilities of this role include site training on the requirements of ALCOA+, ensuring processes and procedures are in place to implement ALCOA+ principles in paper and computerized systems, ensuring that computerized system access controls, audit trail reviews and back-up and restore functions are appropriately implemented and meet cGMP requirements. The site Data Integrity Lead will also have responsibility for implementing and maintaining risk-based methodologies for the assessment and management of data integrity risks. The site Data Integrity Lead will drive a Data Integrity Management program across the Lee, MA manufacturing facility. This site-based role requires a strong leader with excellent communication skills and who is capable of prioritizing and managing multiple projects effectively. The successful candidate will be responsible for ensuring cGMP compliance as it pertains to Data Integrity Management across site operations and for implementing applicable corporate standards locally. Duties and Responsibilities Lead and maintain the site Data Integrity Management Program, including defining site objectives and scope, implementing corporate data integrity requirements, development and refinement of site procedures, implementing processes and metrics to monitor the effectiveness of the site Data Integrity program. Serve as the site Data Integrity subject matter expert (SME) during regulatory inspections and client audits, train/coach personnel on ALCOA+ principles and associated regulations and guidance documents. (e.g. GAMP5, PIC/S, 21 CFR Part 11, EudraLex Annex 11, FDA's Guidance for Industry, "Data Integrity and Compliance with Drug CGMP: Questions and Answers" (Final, 2018 . Report to the Site Quality Head and serve on the site Quality Leadership team and governance forums. Provide leadership and guidance to site functional representatives and system or process owners supporting Data Integrity objectives. Ensure site personnel understand and implement risk-based methodologies are understood and implemented as they pertain to data integrity management, especially when assessing legacy computerized systems, when validating new computerized systems and when evaluating proposed changes to existing computerized systems. Collaborate with the applicable corporate and site Data Governance, Quality, and Information Technology functions to integrate data integrity into the overall data governance framework, with particular emphasis on computerized systems and adherence to ALCOA+ principles. Collaborate cross-site to ensure that roles and responsibilities are clear regarding data management and stewardship of data integrity management. Provide guidance on the process to evaluate data integrity compliance through audits of Sharp and its suppliers. Lead or support site Data Integrity risk assessments, investigations, root cause analyses, corrective and preventive actions, and remediation plans. Ensure Data Integrity considerations are incorporated into computerized system validation, change control, incident management, periodic review, and system retirement activities. Review and trend site Data Integrity metrics, communicate program status and risks to site leadership, and drive continuous improvement and inspection readiness. Monitor relevant regulatory and industry expectations, assess site impact, and coordinate implementation of required site actions. Regulatory Responsibilities Conduct business in a responsible manner that complies with all state, OSHA, and HIPAA regulations Maintain a detailed and comprehensive understanding of FDA, EU, and other regulatory agency requirements as it pertains to data integrity. Supervisory Responsibilities This position has no direct reporting line responsibility; however, it will provide functional leadership and oversight to Data Integrity representatives and subject matter experts embedded within site operational units to support the execution of the Data Integrity Program. Experience Prefer a minimum of 5 years of experience in data management, data governance frameworks, and data quality tools, with a focus on computerized systems and adherence to ALCOA+ principles. Also prefer a minimum of at least 1.5 years in a leadership role within a pharmaceutical operation. Expertise in the application of 21 CFR Part 11, EudraLex Annex 11 and GAMP standards for data integrity and validation of automated systems is required. Proven experience of managing data integrity initiatives, particularly in relation to computerized systems, within a pharmaceutical organization. Experience collaborating cross functionally on investigations, CAPAs, risk assessments, and remediation programs associated with Data Integrity events or observations. Demonstrated history of influencing, motivating and effecting change with cross functional teams. Ability to independently determine and develop approaches to address simple to complex issues. Knowledge of and skill in using computer software and hardware applications. Excellent verbal and written communication/documentation skills with a demonstrated ability to clearly present technical topics to a non technical audience. Ability to influence and engage stakeholders at all levels. Excellent project management skills with the ability to manage multiple initiatives simultaneously. Strong analytical skills with the ability to interpret complex data sets from computerized systems and provide actionable insights. Experience of working in a sterile pharmaceutical manufacturing environment preferred. Education BS or higher degree in an IT, engineering, scientific discipline or other related field. A master's degree is a plus. Knowledge, Skills & Abilities Skilled in the use of Microsoft office applications (Word, Excel, PowerPoint) and Adobe Acrobat High attention to detail Good writing, public speaking and presentation skills Must be able to travel approximately 10% of the time Physical Requirements Ability to sit for prolonged periods of time Ability to stand for prolong periods of time as required Able to lift up to 10lbs