Senior Validation Engineer (Biopharmaceutical)

Location: Geleen, Netherlands; full-time onsite role. Relocation and visa support available.

Annual base pay: €57,000–€79,800.

Company

Biopharmaceutical manufacturing organization operating across more than 30 sites on five continents and developing medicines for customers.

What you will do

• Develop, execute, and review validation plans, IQ, OQ, PQ, and CSV protocols and reports.
• Lead qualification and validation activities for equipment, facilities, utilities, and computerized systems.
• Provide technical guidance and mentorship as a validation subject matter expert.
• Perform FMEA-based risk assessments and define mitigation strategies.
• Investigate deviations, out-of-specification results, and non-conformances, implementing CAPAs.
• Collaborate with Manufacturing, Quality Control, Quality Assurance, Engineering, and IT, while supporting audits, training, and continuous improvement.

Requirements

• Bachelor’s or Master’s degree in Engineering, Biotechnology, or a related scientific discipline.
• At least 7 years of progressive validation experience in the pharmaceutical or biopharmaceutical industry.
• Expertise in validation principles, GxP, FDA 21 CFR Part 11, and related industry standards.
• Proven experience developing and executing IQ, OQ, PQ, and CSV protocols and reports.
• Strong understanding of biopharmaceutical manufacturing processes, associated equipment, and GMP environments.
• Strong analytical, documentation, communication, collaboration, and project management skills.

Nice to have

• Experience with Quality Assurance and quality management systems.
• Experience with Kneat Gx, ValGenesis, TrackWise, Veeva QualityDocs, SAP PM, IBM Maximo, LIMS, MES, or other GxP-regulated computerized systems.

Culture & Benefits

• Agile career environment and dynamic working culture.
• Inclusive and ethical workplace committed to diversity.
• Performance-based compensation programs.
• Benefits vary according to role and location.