Hire IT People Inc
Lebanon, Indiana
Job DescriptionJob Description Job Description Lead the BMS validation lifecycle across all 8 LMF buildings, from URS authoring through Validation Summary Report and closeout. Author and obtain approval for User Requirement Specifications (URS) for the Metasys BMS platform. Engage JCI on Software Requirement Specifications (SRS) review and acceptance. Develop and execute Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols. Risk based approach adhering to Lilly Quality procedures. Generate and maintain requirements traceability matrices (RTMs) linking requirements through design, testing, and acceptance. Author Validation Summary Reports (VSR) documenting validation outcomes, deviations, and acceptance rationale. Perform 21 CFR Part 11 gap assessments for electronic records, electronic signatures, and audit trail compliance across Metasys and AVEVA PI. Coordinate with the Integration Engineer on alarm management validation (ISA 18.2) and OT cybersecurity validation (ISA/IEC 62443). Validate OPC/UA integration between Metasys, AVEVA PI, and DeltaV QBMS. Draft commissioning protocols and support system acceptance testing. Draft and maintain SOPs related to BMS operations, operator training, and preventive maintenance. Enroll systems into the periodic review program for ongoing validated-state maintenance. Support audit readiness by ensuring validation documentation is inspection-ready and aligned with FDA, EMA, and Lilly corporate quality standards. Provide support for data integrity assessments across BMS and historian systems. Assist with commissioning and qualification (C&Q) activities for new BMS equipment. Support remediation of validation findings from internal audits or regulatory inspections. Advise on validation strategy for future BMS system upgrades and expansions. Mandatory skills Demonstrated experience in computer systems validation (CSV) for building management or automation and control systems in a pharmaceutical/GMP-regulated environment. Strong knowledge of GAMP 5 methodology, V-model lifecycle, and risk-based validation approaches. Experience with 21 CFR Part 11 compliance, including assessment of electronic records, electronic signatures, and audit trail requirements. Proficiency in developing validation deliverables: VP, URS, FS, DS, IQ/OQ/PQ protocols, RTMs, and VSRs. Experience with BMS, DCS, PLC/HMI, or historian systems in a manufacturing environment. Strong understanding of FDA and EMA regulatory expectations for computerized system validation. Desired skills Direct experience validating JCI Metasys, Honeywell, Siemens, or similar BMS platforms. Experience with AVEVA PI Historian, DeltaV, or OPC/UA integration validation. Familiarity with ISA 18.2 alarm management and ISA/IEC 62443 cybersecurity standards. Familiarity with data integrity principles (ALCOA+) and data governance frameworks. Experience with Kneat, ValGenesis, or similar electronic validation management systems. Company DescriptionHire IT People, Inc provides full time and contractual IT staffing nationwide. We presently provide services to several governments and state agencies, Fortune 500 companies, and leading mid-market companies in several including healthcare, insurance, retail, state/governments. We serve Government agencies, Fortune 500 and leading mid-market companies across every Industry Our candidate network includes thousands in our database and targeted networks including top social sites We gather information about your future hiring needs to perform a pro-active search, we mostly work with local candidates Our cutting-edge recruitment tools help minimize the complexities of hiring and reaching the right talent We can provide experienced IT Professionals for your IT Projects covering most Technologies and rolesCompany DescriptionHire IT People, Inc provides full time and contractual IT staffing nationwide. We presently provide services to several governments and state agencies, Fortune 500 companies, and leading mid-market companies in several including healthcare, insurance, retail, state/governments. We serve Government agencies, Fortune 500 and leading mid-market companies across every Industry Our candidate network includes thousands in our database and targeted networks including top social sites We gather information about your future hiring needs to perform a pro-active search, we mostly work with local candidates Our cutting-edge recruitment tools help minimize the complexities of hiring and reaching the right talent We can provide experienced IT Professionals for your IT Projects covering most Technologies and roles
Job DescriptionJob Description Job Description Lead the BMS validation lifecycle across all 8 LMF buildings, from URS authoring through Validation Summary Report and closeout. Author and obtain approval for User Requirement Specifications (URS) for the Metasys BMS platform. Engage JCI on Software Requirement Specifications (SRS) review and acceptance. Develop and execute Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols. Risk based approach adhering to Lilly Quality procedures. Generate and maintain requirements traceability matrices (RTMs) linking requirements through design, testing, and acceptance. Author Validation Summary Reports (VSR) documenting validation outcomes, deviations, and acceptance rationale. Perform 21 CFR Part 11 gap assessments for electronic records, electronic signatures, and audit trail compliance across Metasys and AVEVA PI. Coordinate with the Integration Engineer on alarm management validation (ISA 18.2) and OT cybersecurity validation (ISA/IEC 62443). Validate OPC/UA integration between Metasys, AVEVA PI, and DeltaV QBMS. Draft commissioning protocols and support system acceptance testing. Draft and maintain SOPs related to BMS operations, operator training, and preventive maintenance. Enroll systems into the periodic review program for ongoing validated-state maintenance. Support audit readiness by ensuring validation documentation is inspection-ready and aligned with FDA, EMA, and Lilly corporate quality standards. Provide support for data integrity assessments across BMS and historian systems. Assist with commissioning and qualification (C&Q) activities for new BMS equipment. Support remediation of validation findings from internal audits or regulatory inspections. Advise on validation strategy for future BMS system upgrades and expansions. Mandatory skills Demonstrated experience in computer systems validation (CSV) for building management or automation and control systems in a pharmaceutical/GMP-regulated environment. Strong knowledge of GAMP 5 methodology, V-model lifecycle, and risk-based validation approaches. Experience with 21 CFR Part 11 compliance, including assessment of electronic records, electronic signatures, and audit trail requirements. Proficiency in developing validation deliverables: VP, URS, FS, DS, IQ/OQ/PQ protocols, RTMs, and VSRs. Experience with BMS, DCS, PLC/HMI, or historian systems in a manufacturing environment. Strong understanding of FDA and EMA regulatory expectations for computerized system validation. Desired skills Direct experience validating JCI Metasys, Honeywell, Siemens, or similar BMS platforms. Experience with AVEVA PI Historian, DeltaV, or OPC/UA integration validation. Familiarity with ISA 18.2 alarm management and ISA/IEC 62443 cybersecurity standards. Familiarity with data integrity principles (ALCOA+) and data governance frameworks. Experience with Kneat, ValGenesis, or similar electronic validation management systems. Company DescriptionHire IT People, Inc provides full time and contractual IT staffing nationwide. We presently provide services to several governments and state agencies, Fortune 500 companies, and leading mid-market companies in several including healthcare, insurance, retail, state/governments. We serve Government agencies, Fortune 500 and leading mid-market companies across every Industry Our candidate network includes thousands in our database and targeted networks including top social sites We gather information about your future hiring needs to perform a pro-active search, we mostly work with local candidates Our cutting-edge recruitment tools help minimize the complexities of hiring and reaching the right talent We can provide experienced IT Professionals for your IT Projects covering most Technologies and rolesCompany DescriptionHire IT People, Inc provides full time and contractual IT staffing nationwide. We presently provide services to several governments and state agencies, Fortune 500 companies, and leading mid-market companies in several including healthcare, insurance, retail, state/governments. We serve Government agencies, Fortune 500 and leading mid-market companies across every Industry Our candidate network includes thousands in our database and targeted networks including top social sites We gather information about your future hiring needs to perform a pro-active search, we mostly work with local candidates Our cutting-edge recruitment tools help minimize the complexities of hiring and reaching the right talent We can provide experienced IT Professionals for your IT Projects covering most Technologies and roles
Hire IT People Inc
Des Moines, Iowa
Job DescriptionJob Description Job Title: Cloud, Platform, Systems Specialist Location: Des Moines, Iowa Work Arrangement: Onsite ONLY. Local and regional candidates required to work onsite ONLY. US Citizen only. Duration: Long term, one year plus extensions. Need 3 professional references. Job Summary: Des Moines, Iowa (Onsite), US Citizen only, Cloud, Platform, Systems Specialist, design & administer AWS environments - EC2, VPC, IAM, S3, Create workload patterns, legacy systems to AWS, AWS architecture. Job Description: The Service Delivery Public Safety IT Team is seeking a candidate for a critical cloud/platform/systems specialist to Support senior resources. The Service Delivery Public Safety IT Team is seeking a candidate for a critical cloud/platform/systems specialist to Support senior resources. Expectations include Leading infrastructure initiatives to modernize IT infrastructure and operations to enhance efficiency, scalability, and reliability across hybrid cloud environments. This role supports enterprise modernization goals by providing support for modern approaches to hybrid-cloud administrative and engineering practices to eliminate expensive and inefficient legacy solutions, while improving operational efficiency, reducing manual intervention, and enabling scalable infrastructure solutions. 5 or more years of experience required in the following areas: Designs, maintains, and optimizes hybrid platforms that bridge on premises infrastructure with AWS cloud services, aligning with the shift toward cloud centric operations: - Designing and administering AWS environments (EC2, VPC, IAM, S3) to support enterprise workloads. - Creating hybrid workload patterns where identity, authentication, and application services function seamlessly across cloud and on premises systems. - Migrating legacy systems to AWS, including developing modernization roadmaps and workload readiness assessments. - Documenting system architectures and producing AWS architecture diagrams showing network topology, dependencies, and service interactions. Provides senior tier support for issues escalated from Service Desk, Applications, Networking, or automation teams: - Diagnosing complex AWS identity, network, or compute issues affecting dependent applications. - Documenting troubleshooting workflows, root causes, and long term mitigation strategies. - Guiding teams through hybrid dependency failures such as directory sync disruptions, routing conflicts, or misconfigured IAM policies. Ensures platform resilience by monitoring, optimizing, and maintaining cloud and on prem compute, storage, networking, and identity components: - Eliminate single points of failure in designs patterns - Provide backup, recovery, and DR to meet all RTO/RPO requirements. - Implementing performance dashboards covering compute utilization, storage I/O, and network throughput across AWS and on prem. - Conducting root cause analysis for performance issues and documenting remediation steps. - Identifying cost optimization opportunities through instance rightsizing, storage tier adjustments, and lifecycle automation. - Maintaining architecture diagrams, standards, IaC manifests, and operational procedures in version controlled environments. - Preparing change impact statements for major infrastructure modifications. - Creating release documentation for platform updates promoted through CI/CD pipelines. Ensuring consistency across platform standards, enforcement rules, and automation artifacts. Works closely with automation specialist and other team members to ensure infrastructure deployments follow consistent, automated, and auditable patterns: - Defining IaC patterns and collaborating on Terraform module designs. - Documenting provisioning workflows, configuration standards, and parameter usage for automated deployments. - Supporting CI/CD infrastructure pipelines that promote test, staging, and production environments through automated checks. - Collaborate with engineering and application teams to optimize workloads for hybrid cloud environments. - Provide guidance on migration strategies, performance tuning, and cost optimization for hybrid-cloud deployments. Maintain comprehensive documentation for hybrid cloud architecture, operational procedures, and automation workflows. Ensure documentation supports knowledge transfer and compliance audits. Supports organizational security and compliance goals by implementing and documenting platform controls across cloud and on prem environments. Responsibilities include, but are not limited to: - Enforcing AWS guardrails such as encryption, MFA, IAM role boundaries, and network segmentation. - Producing audit evidence packages (configuration exports, pipeline logs, screenshots). - Documenting platform hardening guidelines for compute, identity, and storage systems. - Creating policy interpretation guides to clarify required platform configurations for other technical teams. - Writing operational guides, onboarding materials, and "how to" documentation for AWS and hybrid operations. - Delivering platform standards, architecture reference materials, and annotated diagrams explaining system interactions. - Producing executive level briefings summarizing modernization progress and platform initiatives. Company DescriptionHire IT People, Inc provides full time and contractual IT staffing nationwide. We presently provide services to several governments and state agencies, Fortune 500 companies, and leading mid-market companies in several including healthcare, insurance, retail, state/governments. We serve Government agencies, Fortune 500 and leading mid-market companies across every Industry Our candidate network includes thousands in our database and targeted networks including top social sites We gather information about your future hiring needs to perform a pro-active search, we mostly work with local candidates Our cutting-edge recruitment tools help minimize the complexities of hiring and reaching the right talent We can provide experienced IT Professionals for your IT Projects covering most Technologies and rolesCompany DescriptionHire IT People, Inc provides full time and contractual IT staffing nationwide. We presently provide services to several governments and state agencies, Fortune 500 companies, and leading mid-market companies in several including healthcare, insurance, retail, state/governments. We serve Government agencies, Fortune 500 and leading mid-market companies across every Industry Our candidate network includes thousands in our database and targeted networks including top social sites We gather information about your future hiring needs to perform a pro-active search, we mostly work with local candidates Our cutting-edge recruitment tools help minimize the complexities of hiring and reaching the right talent We can provide experienced IT Professionals for your IT Projects covering most Technologies and roles
Job DescriptionJob Description Job Title: Cloud, Platform, Systems Specialist Location: Des Moines, Iowa Work Arrangement: Onsite ONLY. Local and regional candidates required to work onsite ONLY. US Citizen only. Duration: Long term, one year plus extensions. Need 3 professional references. Job Summary: Des Moines, Iowa (Onsite), US Citizen only, Cloud, Platform, Systems Specialist, design & administer AWS environments - EC2, VPC, IAM, S3, Create workload patterns, legacy systems to AWS, AWS architecture. Job Description: The Service Delivery Public Safety IT Team is seeking a candidate for a critical cloud/platform/systems specialist to Support senior resources. The Service Delivery Public Safety IT Team is seeking a candidate for a critical cloud/platform/systems specialist to Support senior resources. Expectations include Leading infrastructure initiatives to modernize IT infrastructure and operations to enhance efficiency, scalability, and reliability across hybrid cloud environments. This role supports enterprise modernization goals by providing support for modern approaches to hybrid-cloud administrative and engineering practices to eliminate expensive and inefficient legacy solutions, while improving operational efficiency, reducing manual intervention, and enabling scalable infrastructure solutions. 5 or more years of experience required in the following areas: Designs, maintains, and optimizes hybrid platforms that bridge on premises infrastructure with AWS cloud services, aligning with the shift toward cloud centric operations: - Designing and administering AWS environments (EC2, VPC, IAM, S3) to support enterprise workloads. - Creating hybrid workload patterns where identity, authentication, and application services function seamlessly across cloud and on premises systems. - Migrating legacy systems to AWS, including developing modernization roadmaps and workload readiness assessments. - Documenting system architectures and producing AWS architecture diagrams showing network topology, dependencies, and service interactions. Provides senior tier support for issues escalated from Service Desk, Applications, Networking, or automation teams: - Diagnosing complex AWS identity, network, or compute issues affecting dependent applications. - Documenting troubleshooting workflows, root causes, and long term mitigation strategies. - Guiding teams through hybrid dependency failures such as directory sync disruptions, routing conflicts, or misconfigured IAM policies. Ensures platform resilience by monitoring, optimizing, and maintaining cloud and on prem compute, storage, networking, and identity components: - Eliminate single points of failure in designs patterns - Provide backup, recovery, and DR to meet all RTO/RPO requirements. - Implementing performance dashboards covering compute utilization, storage I/O, and network throughput across AWS and on prem. - Conducting root cause analysis for performance issues and documenting remediation steps. - Identifying cost optimization opportunities through instance rightsizing, storage tier adjustments, and lifecycle automation. - Maintaining architecture diagrams, standards, IaC manifests, and operational procedures in version controlled environments. - Preparing change impact statements for major infrastructure modifications. - Creating release documentation for platform updates promoted through CI/CD pipelines. Ensuring consistency across platform standards, enforcement rules, and automation artifacts. Works closely with automation specialist and other team members to ensure infrastructure deployments follow consistent, automated, and auditable patterns: - Defining IaC patterns and collaborating on Terraform module designs. - Documenting provisioning workflows, configuration standards, and parameter usage for automated deployments. - Supporting CI/CD infrastructure pipelines that promote test, staging, and production environments through automated checks. - Collaborate with engineering and application teams to optimize workloads for hybrid cloud environments. - Provide guidance on migration strategies, performance tuning, and cost optimization for hybrid-cloud deployments. Maintain comprehensive documentation for hybrid cloud architecture, operational procedures, and automation workflows. Ensure documentation supports knowledge transfer and compliance audits. Supports organizational security and compliance goals by implementing and documenting platform controls across cloud and on prem environments. Responsibilities include, but are not limited to: - Enforcing AWS guardrails such as encryption, MFA, IAM role boundaries, and network segmentation. - Producing audit evidence packages (configuration exports, pipeline logs, screenshots). - Documenting platform hardening guidelines for compute, identity, and storage systems. - Creating policy interpretation guides to clarify required platform configurations for other technical teams. - Writing operational guides, onboarding materials, and "how to" documentation for AWS and hybrid operations. - Delivering platform standards, architecture reference materials, and annotated diagrams explaining system interactions. - Producing executive level briefings summarizing modernization progress and platform initiatives. Company DescriptionHire IT People, Inc provides full time and contractual IT staffing nationwide. We presently provide services to several governments and state agencies, Fortune 500 companies, and leading mid-market companies in several including healthcare, insurance, retail, state/governments. We serve Government agencies, Fortune 500 and leading mid-market companies across every Industry Our candidate network includes thousands in our database and targeted networks including top social sites We gather information about your future hiring needs to perform a pro-active search, we mostly work with local candidates Our cutting-edge recruitment tools help minimize the complexities of hiring and reaching the right talent We can provide experienced IT Professionals for your IT Projects covering most Technologies and rolesCompany DescriptionHire IT People, Inc provides full time and contractual IT staffing nationwide. We presently provide services to several governments and state agencies, Fortune 500 companies, and leading mid-market companies in several including healthcare, insurance, retail, state/governments. We serve Government agencies, Fortune 500 and leading mid-market companies across every Industry Our candidate network includes thousands in our database and targeted networks including top social sites We gather information about your future hiring needs to perform a pro-active search, we mostly work with local candidates Our cutting-edge recruitment tools help minimize the complexities of hiring and reaching the right talent We can provide experienced IT Professionals for your IT Projects covering most Technologies and roles