CQV Documentation Specialist

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.

• 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 engineering, automation, and process inputs into clear, structured, user-friendly documentation.
• Develop and maintain equipment lifecycle documentation such as FAT/SAT reports, calibration records, and equipment traceability matrices.
• Support development of P&IDs, functional specifications, and system descriptions by drafting corresponding narrative documents.
• Author, revise, and finalize equipment-related SOPs, work instructions, and operational guidelines for manufacturing teams.
• Perform and document risk assessments (FMEA, risk ranking, impact assessments) for CQV and equipment qualification.
• Support change control processes by preparing impact assessments and technical rationales.
• Ensure documentation complies with FDA, EMA, ICH Q7/Q8/Q9/Q10, GAMP 5, and cGMP requirements.
• Prepare documentation packages for internal audits, vendor audits, and regulatory inspections.
• Ensure all CQV documentation is inspection-ready, traceable, and fully aligned with qualification requirements.
• Experience in CQV, validation, or documentation within GMP-regulated pharma/biopharma settings.
• Strong understanding of equipment commissioning, qualification, and validation principles.
• Excellent technical writing skills with the ability to interpret engineering drawings, P&IDs, and automation logic.
• Familiarity with pharmaceutical manufacturing processes (bioreactors, filtration systems, chromatography, fill-finish, utilities, etc.).
• Experience with document management systems (Veeva, Master Control, Documentum, etc.) preferred.
• Knowledge of GMP, GAMP 5, 21 CFR Part 11, and validation lifecycle principles.