Quality Assurance Engineer

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.