Temporary Position Validation Engineer

Your Impact

You will turn complex validation requirements into clear, executable plans that deliver reliable performance that can be defended during audits. You will lead deviation investigations to root cause, define effective CAPAs, and maintain alignment with evolving regulatory expectations. You’ll drive cross-site consistency in validation strategy, documentation, and execution—raising the bar for speed, quality, and compliance. You will mentor junior staff and contractors in core validation principles and biotech processes, ensuring knowledge is transferred and standards are upheld. You’ll part of regulatory inspections, presenting protocols, rationales, and outcomes with confidence and technical clarity. And you will safeguard validated states through robust change control, thoughtful impact assessments, and data-driven decision-making.

What You’ll Do

• Prepare, execute, and finalize validation protocols and reports (VPP/VFR, IQ/OQ/PQ) for equipment and process validation, providing protocol training and on-the-floor support.
• Investigate deviations, assess regulatory changes, drive root cause and CAPA with cross-functional partners, and prevent recurrence across sites.
• Lead/participate in cross-site validation improvements; ensure consistency in approaches, documentation, and execution; mentor junior staff and oversee contractors as needed.
• Perform final review of test data/reports for conformance to specifications and SOPs; manage change control impact assessments; represent validation in audits and inspections.

Qualifications

3-5 years of validation/qualification experience preferably with prior knowledge regarding cleaning validation.

Required

• Proven experience preparing and executing equipment and cleaning validation (VPP/VFR, IQ, OQ, PQ) in a GMP-regulated biotech/biopharma environment.
• Strong deviation investigation skills with demonstrated root cause analysis and effective CAPA implementation.
• Solid understanding of regulatory requirements and guidance (e.g., FDA, EMA/EMEA, ICH, EU Annex 15, GAMP principles) and their application to validation.
• Excellent cross-functional collaboration and communication; confident representing validation during audits/inspections.
• Proficiency with validation documentation, change control, risk management, and data review against specifications and SOPs.
• Ability to mentor/coach junior team members and support on-the-floor execution.

Preferred

• BS/MS in Engineering, Life Sciences, or related discipline with 3–5+ years of validation experience in biopharma/biotech or CDMO.
• Experience leading cross-site standardization initiatives and supervising contractors.
• Familiarity with digital validation tools, eQMS, and data systems that enhance efficiency and data integrity.
• Demonstrated success driving continuous improvement in validation lifecycle management.

The Team and Our Culture

At FUJIFILM Biotechnologys Denmark, innovation and execution go hand in hand. You’ll join a highly skilled, collaborative technical team that values scientific rigor, continuous learning, and shared success. We support your growth with meaningful challenges, exceptional teammates, and opportunities to shape how lifesaving therapies reach patients.

How to Apply

Submit your CV highlighting your equipment/process validation experience, deviation investigations, audit representation, and cross-functional leadership. We look forward to seeing how you’ll elevate our compliance and delivery excellence.