Validation Engineer

Advance compliance and operational excellence. As a Validation Engineer, you will prepare, execute, and finalize validation protocols that bring new and modified equipment and processes into our facility. You’ll be a go to person for execution support, preparing validation plans and reports, IQ, OQ, and PQ activities meet regulatory expectations and are executed right the first time. You’ll partner closely with Engineering, Manufacturing, QA, and QE to resolve issues, prevent recurrence, and sustain validated states across our operations.

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.

FUJIFILM Biotechnologys is a global leader in biologics contract development and manufacturing (CDMO), partnering with innovative biotech and biopharma companies to transform healthcare. With locations in Denmark, the UK, and the USA, we support every stage of our customers’ product lifecycle—from breakthrough cures to life-saving vaccines.

Our success starts with our people—their passion drives progress, innovation, and impact. Join a diverse, inclusive workplace that values collaboration, fosters growth, and empowers future generations. Together, we’re enriching communities, protecting the environment, and reimagining healthcare’s potential.

Shape the future with us—your drive meets boundless opportunity here: https://fujifilmdiosynth.com/

FUJIFILM Biotechnologys Denmark (FDBD) is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, sexual orientation, gender identity, or any other protected class.

To all agencies: Please, no phone calls or emails to any employee of FUJIFILM about this requisition. All resumes submitted by search firms/employment agencies to any employee at FUJIFILM via email, the internet, or any form/method will be deemed the sole property of FUJIFILM, unless such firms were engaged by FUJIFILM for this requisition and a valid agreement is in place. In the event a candidate submitted outside of the FUJIFILM agency engagement process is hired, no fee will be paid.