Computerized System Validation Consultant - Global Compliance Partners : Job Details

Computerized System Validation ConsultantComputerized System Validation Consultant

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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 levelMid-Senior level

Employment type

• Employment typeContract

Job function

• Job functionInformation Technology, Engineering, and Quality Assurance
• IndustriesPharmaceutical Manufacturing

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