CSV Engineer (6-Month Contract) – Netherlands
📍 Location: Netherlands (Onsite / Hybrid)
🕒 Employment Type: Full-Time Contract (6 months)
🏭 Industry: Pharmaceuticals / Biotech / CDMO
About the Role
We are recruiting on behalf of our client for an experienced CSV (Commissioning, Qualification & Validation) Engineer to join their quality and engineering team on a 6-month full-time contract. The successful candidate will ensure that equipment, systems, and processes are installed, commissioned, qualified, and validated according to GMP and regulatory standards.
Key Responsibilities
- Develop and execute commissioning, qualification, and validation (IQ, OQ, PQ) protocols
- Perform risk assessments and system verifications
- Prepare, review, and approve validation documentation
- Support equipment and facility qualification for commercial and clinical manufacturing
- Investigate and resolve validation deviations, ensuring CAPA implementation
- Collaborate with QA, Engineering, Manufacturing, and IT teams
- Support regulatory inspections and audits related to validation activities
- Contribute to continuous improvement initiatives in validation processes
Requirements
- Bachelor’s or Master’s degree in Engineering, Biotechnology, Pharmaceutical Sciences, or related field
- 3+ years experience in GMP-regulated commissioning, qualification, and validation
- Strong knowledge of CSV principles, GAMP5, GMP, FDA, EMA, and ICH guidelines
- Experience in computer system validation (software, SCADA, MES, LIMS) is a plus
- Excellent documentation, analytical, and communication skills
- Fluent in English; Dutch is advantageous
If you are interested in this role please apply and if successful I shall reach out to you in due course.