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. 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 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 docu