Job Description


Summary:
  • The CQV Documentation Specialist is responsible for creating, reviewing, and maintaining high-quality documentation that supports commissioning, qualification, and validation (CQV) activities for manufacturing process equipment in GMP-regulated pharmaceutical and biopharmaceutical environments. This role ensures all documentation—protocols, reports, SOPs, risk assessments, and equipment lifecycle documents—is accurate, compliant, and audit-ready.
    • Roles & Responsibilities:
  • Prepare, write, and revise CQV documents including URS, DQ, IQ, OQ, PQ protocols and summary reports.

  • Draft equipment and system-specific documentation for reactors, bioreactors, chromatography skids, filtration systems, buffer prep systems, filling lines, HVAC, WFI/clean utilities, CIP/SIP systems, etc.

  • Create validation test scripts, data sheets, and acceptance criteria aligned with cGMP and regulatory expectations.

  • Convert complex eng...

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