Barrington James
Quality Assurance Engineer
Barrington JamesNetherlands1 day ago
ContractRemote FriendlyQuality Assurance

CSV Engineer (6-Month Contract) – Netherlands


📍 Location: Netherlands (Onsite / Hybrid)

đź•’ 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.