CQV ENGINEER

You will help create, organize, execute, and close out commissioning and qualification documentation that supports clinical manufacturing operations. The position will emphasize generation and execution of IQ/OQ/PQ protocols, commissioning activities, discrepancy and deviation management, coordination with system owners and vendors, and close collaboration with Engineering, Manufacturing, Quality, Facilities, and Operations teams.

• Generate, review, revise, and execute CQV documentation, including User Requirements Specifications (URS), Risk Assessments, Impact Assessments, Requirement Traceability Matrices (RTMs), Commissioning Protocols, IQ/OQ/PQ protocols, discrepancy documentation, and summary reports.
• Execute commissioning and qualification protocols in the field for GMP manufacturing equipment, utilities, laboratory equipment, computerized systems and related support systems.
• Support the protocol lifecycle from drafting and routing through execution, data review, discrepancy resolution, report generation, and closeout.
• Support facility startup and commissioning activities, including system walkdowns, turnover package review, P&, punch list management, component verification, operational readiness, and field coordination.
• Conduct or support risk assessments and impact assessments, establish or document system boundaries, and translate assessment outputs into practical CQV deliverables under appropriate technical and Quality oversight.
• Author, review, and revise standard operating procedures, work instructions, and supporting GMP documentation as needed.
• Investigate, document and support the resolution and closeout of discrepancies and deviations, including impact assessment, corrective actions, and retest activities as appropriate.
• Coordinate with Engineering, Manufacturing, Quality, Facilities, Operations, system owners, and external vendors to plan execution windows, resolve field issues, and drive assigned deliverables to completion.
• Own defined CQV deliverables, equipment packages, or execution work streams commensurate with experience, with guidance from senior technical and Quality team members.

• Bachelor’s degree in engineering, life sciences, or an equivalent technical discipline preferred.
• 2–5 years of experience in commissioning, qualification, CQV, manufacturing, engineering, facilities, operations, quality, or another GMP technical role; candidates with direct hands‑on CQV execution experience are strongly encouraged to apply.
• Experience in clinical manufacturing, start‑up, or early‑stage biopharmaceutical environments is a plus, particularly where responsibilities included both documentation and field execution.
• Hands‑on technical experience involving manufacturing equipment, utilities, process systems, laboratories, computerized systems, temperature‑controlled units, or GMP documentation is valued.
• Strong technical writing skills with the ability to produce clear, accurate, inspection‑ready protocols, forms, reports, SOPs, and supporting documentation.
• Comfortable performing hands‑on protocol execution, including observing equipment operation, recording data, following procedures, coordinating with system owners, and escalating issues appropriately.
• Experience with facility startup, commissioning, system turnover, P&, field verification, punch list closure, vendor startup activities, and GMP readiness is preferred.
• Experience with Computer System Validation (CSV) and knowledge of FDA 21 CFR Part 11 compliance, data integrity requirements, and GxP computerized systems is preferred.
• Familiarity with GMP documentation practices, ALCOA principles, change control, discrepancy/deviation documentation, impact…