CQV Engineer

Overview

We are looking for a highly skilled and driven Commissioning, Qualification & Validation (CQV) Engineer to join a new project team in France. You will play a pivotal role in the delivery of a brand‑new, state‑of‑the‑art life sciences manufacturing facility.

Responsibilities

• Protocol Generation & Execution: Author, review, and execute commissioning and qualification documentation, including Impact Assessments, User Requirement Specifications (URS), Commissioning plans, Installation/Operational/Performance Qualification (IQ/OQ/PQ) protocols, and summary reports.
• Equipment & Utilities Focus: Lead CQV activities for core manufacturing systems (e.g., bioreactors, purification skids, autoclaves, formulation vessels) and critical utilities (WFI, Pure Steam, Clean Compressed Air, and HVAC system).
• Vendor Management: Coordinate with equipment vendors, engineering contractors, and construction teams during Factory Acceptance Testing (FAT) and Site Acceptance Testing (SAT).
• Deviation & Problem Solving: Identify, investigate, and document deviations during execution. Work closely with Engineering and Quality Assurance to implement robust corrective actions (CAPA).
• Risk-Based Qualification: Apply Quality Risk Management (QRM) principles, utilizing ASTM E2500 frameworks to streamline validation efforts without compromising quality.
• Safety & Walkdowns: Participate in system mechanical completion walkdowns, P&ID checking, and safety reviews before starting physical testing.

Qualifications & Requirements

• Education: Bachelor’s degree in Chemical Engineering, Mechanical Engineering, Bioengineering, or a related technical discipline.
• Experience: Minimum of 3–5 years of CQV experience within a GMP‑regulated pharmaceutical, biopharmaceutical, or vaccine manufacturing environment.
• Project Experience: Direct experience working on large‑scale equipment installation or new manufacturing facility delivery.
• Technical Knowledge: Strong working knowledge of EU GMP Annex 1, FDA regulations, and ISPE guidelines.
• Hands‑on Familiarity: Process piping, sanitary design principles, and cleanroom qualification.