CSV Engineer

We are seeking an experienced and dynamic Computer System Validation (CSV) Enginee r to join a growing engineering team in France. This role is a unique opportunity to be part of a major, state-of-the-art manufacturing facility buil d from the ground up

.As a core member of the CQV (Commissioning, Qualification, and Validation) team, you will lead the validation efforts for all computerized systems, automated equipment, and IT infrastructure ensuring full compliance with Data Integrity, GAMP 5, and global regulatory standards (EMA, FDA). If you thrive in fast-paced project environments and want to leave your mark on a brand-new facility, this is the role for yo

u.Key Responsibilities of the CSV Engine

• er Validation Strategy & Executi on: Author, review, and execute CSV lifecycle deliverables, including Validation Plans, User Requirement Specifications (URS), Risk Assessments, Functional Specifications, IQ/OQ/PQ protocols, and Validation Summary Repor
• ts.New Facility Integrati on: Collaborate closely with automation and IT vendors to validate a brand-new suite of systems including SCADA, MES, Distributed Control Systems (DCS), PLC-based manufacturing equipment, and lab instrumentation (LIM
• S).Compliance & Data Integri ty: Ensure all computerized systems comply with 21 CFR Part 11, EU GMP Annex 11, and ALCOA+ data integrity principl
• es.Risk Manageme nt: Lead Quality Risk Management (QRM) assessments (FMEA, PHA) to define the scope of validation testing based on critical quality attributes (CQAs) and critical process parameters (CPP
• s).Cross-Functional Collaborati on: Partner with Quality Assurance, Engineering, Automation, and IT to align validation activities with the master project timeli
• ne.Defect & Deviation Manageme nt: Investigate, log, and resolve deviations and non-conformances discovered during protocol executi

on.Qualifications & Requirements of the CSV Engi

• neerEducat ion: Bachelor’s degree in Engineering, Computer Science, Life Sciences, or a related technical discipl
• ine.Experie nce: Minimum of 4–6 years of experience in Computer System Validation (CSV) within the pharmaceutical, biopharmaceutical, or medical device industr
• ies.Project Experie nce: Proven track record of working on large-scale capital expenditure (CAPEX) facility bu ilds or new production line installati
• ons.Technical Knowle dge: * Strong understanding of GA MP 5 methodology and lifecycle appro
• ach.Deep familiarity with automated manufacturing systems (e.g., Siemens, Rockwell, DeltaV, Emers
• on).In-depth knowledge of FDA 21 CFR Part 11 and EU Annex 11 regulati
• ons.Ski lls: Excellent technical writing skills, high attention to detail, and a proactive problem-solving mind