Global Compliance Partners
Computerized System Validation Consultant
Global Compliance Partners - Phila, Pennsylvania, United States
Work at Global Compliance Partners
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Overview
Computerized System Validation Consultant
Computerized System Validation Consultant
Get AI-powered advice on this job and more exclusive features. Global Compliance Partners is seeking a highly motivated and detail-oriented CMMS Validation Engineer to lead and support computerized system validation (CSV) efforts for Computerized Maintenance Management Systems (CMMS) in a GMP-regulated environment. This role will also provide ancillary support for equipment validation documentation, including the update of validation packages (IQ, OQ, PQ) in alignment with site procedures and current regulatory expectations. Key Responsibilities Primary Duties – CMMS Validation Lead the validation lifecycle of CMMS systems (e.g., Blue Mountain, Maximo, eMaint) including User Requirements, Functional and Design Specifications, Risk Assessments, and Test Protocols (IQ/OQ/PQ). Develop and execute validation plans in accordance with GAMP 5, 21 CFR Part 11, Annex 11, and internal SOPs. Partner with cross-functional stakeholders (QA, Engineering, Facilities, IT) to align system configuration and workflow with GMP compliance expectations. Perform periodic review assessments and revalidation as needed. Maintain traceability matrix linking requirements to test evidence. Support audit readiness and provide documentation during internal or regulatory inspections. Update or revise equipment validation documentation (URS, DQ, IQ, OQ, PQ) for GMP-critical systems as needed. Review existing equipment validation packages for alignment with current site validation master plan and regulatory guidance. Collaborate with SMEs to gather technical specifications and historical data for equipment updates. Author summary reports to document retrospective qualification or change-driven requalification activities. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Contract Job function
Job function Information Technology, Engineering, and Quality Assurance Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Global Compliance Partners by 2x Get notified about new Validation Consultant jobs in
Pennsylvania, United States . QA Product Validation and Approval Specialist
Scientist II: Method Development and Validation
Scientist II: Method Development and Validation
Leave Solutions Sr. Client Representative
Leave Solutions Sr. Client Representative
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Computerized System Validation Consultant
Get AI-powered advice on this job and more exclusive features. Global Compliance Partners is seeking a highly motivated and detail-oriented CMMS Validation Engineer to lead and support computerized system validation (CSV) efforts for Computerized Maintenance Management Systems (CMMS) in a GMP-regulated environment. This role will also provide ancillary support for equipment validation documentation, including the update of validation packages (IQ, OQ, PQ) in alignment with site procedures and current regulatory expectations. Key Responsibilities Primary Duties – CMMS Validation Lead the validation lifecycle of CMMS systems (e.g., Blue Mountain, Maximo, eMaint) including User Requirements, Functional and Design Specifications, Risk Assessments, and Test Protocols (IQ/OQ/PQ). Develop and execute validation plans in accordance with GAMP 5, 21 CFR Part 11, Annex 11, and internal SOPs. Partner with cross-functional stakeholders (QA, Engineering, Facilities, IT) to align system configuration and workflow with GMP compliance expectations. Perform periodic review assessments and revalidation as needed. Maintain traceability matrix linking requirements to test evidence. Support audit readiness and provide documentation during internal or regulatory inspections. Update or revise equipment validation documentation (URS, DQ, IQ, OQ, PQ) for GMP-critical systems as needed. Review existing equipment validation packages for alignment with current site validation master plan and regulatory guidance. Collaborate with SMEs to gather technical specifications and historical data for equipment updates. Author summary reports to document retrospective qualification or change-driven requalification activities. Seniority level
Seniority level Mid-Senior level Employment type
Employment type Contract Job function
Job function Information Technology, Engineering, and Quality Assurance Industries Pharmaceutical Manufacturing Referrals increase your chances of interviewing at Global Compliance Partners by 2x Get notified about new Validation Consultant jobs in
Pennsylvania, United States . QA Product Validation and Approval Specialist
Scientist II: Method Development and Validation
Scientist II: Method Development and Validation
Leave Solutions Sr. Client Representative
Leave Solutions Sr. Client Representative
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We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.
#J-18808-Ljbffr