Senior Validation Engineer / Validation SME – Cleanrooms, Classified Environments, and Clean Utilities

Senior Va lidation Engineer / Validation SME – Cleanroom s, Classified Environments , and Clean Utilities

FUJIFILM Biotechnologies (FLBD) is seeking an experienced Senior Validation Engineer / Validation Subject Matter Expert (SME) to drive validation activities related to Cleanrooms and Classified Environments (including supporting HVAC systems) , and Clean Utilities, including compendial water, steam and process gases .

This is a highly visible role requiring deep technical expertise, strong regulatory knowledge, and the ability to provide strategic direction for qualification and validation activities for c ontrolled GMP e nvironments and clean utilities . The successful candidate will act as validation SME within the area and play a key role in ensuring compliance with global regulatory requirements while supporting ongoing operations, expansion projects, and inspection readiness.

Main responsibilitie s

• Serve as Validation SME for Clean Utilities and Cleanrooms / Classified Environments , including HVAC and Environmental Control Systems

• Technical ownership of the validation program for Cleanrooms and Clean Air Devices (e.g., Laminar Flow Hoods and Biological Safety Cabinets)

• Act as validation SME during customer audits & regulatory agency inspections.

• Drive inspection readiness activities and support remediation of audit observations and regulatory commitments

• Decision-making authority on validation strategy and risk-based approaches

• Own and maintain the validation strategy and validated state for facilities and utility systems throughout their lifecycle

• Lead and approve validation activities including VPP, Commissioning & Qualification Strategies, Quality Risk Assessments, IQ, OQ, PQ, RQ, and Continued Lifecycle Verification

• Provide technical validation ownership on cleanroom qualification and classification, including smoke studies / airflow visualization, pressure cascade and air exchange rate assessments, environmental qualification, HEPA filter integrity testing, temperature and humidity mapping, utility qualification, and Contamination Control Strategy (CCS)

• Lead Quality Risk Assessments and impact assessments related to deviations, CAPAs, change controls, investigations, and system improvements.

Qualifications

• Bachelor's, Master's, or equivalent degree within Engineering, Biotechnology, Pharmaceutical Sciences, or a related discipline.

• At least 15 years of relevant HVA C / Cleanroom and Clean Utility GMP validation experience within pharmaceutical, biotechnology, or life science industries.

• Extensive experience qualifying and maintaining HVAC Systems / Classified Cleanrooms, Clean Air Devices and Clean Utilities.

• Strong experience with VPP development, IQ/OQ/PQ, Requalification programs, Quality Risk Management, Change Control, Deviations, Investigations, CAPAs, and Commissioning , Qualification & Validation (CQ V ).

• Proven experience developing validation strategies and lifecycle approaches for complex GMP systems.

• Deep knowledge of EU GMP Annex 1, EU GMP Annex 15, ICH Q8/Q9/Q10, ISPE Guidance , ISO 14644 cleanroom standards, ASTM E2500, GAMP Principles, FDA regulations, and regulatory requirements.

• Demonstrated experience supporting regulatory inspections and responding to observations from health authorities and customers.

Personal skills:

• Confident in challenging technical decisions and influencing stakeholders.

• Pragmatic, solution-oriented, and capable of balancing compliance with business needs.

• Self-driven and comfortable operating with a high degree of autonomy.

• Skilled at creating structure, establishing priorities, and driving execution.

• Able to manage multiple critical activities simultaneously and deliver to demanding timelines.

• Comfortable working across all organizational levels.

• Respected for technical credibility, professionalism, collaboration and stakeholder management.

• Passionate about quality, compliance, and continuous improvement.

The Validation department is responsible for maintaining the validated state of Facility, Utility and Equipment Systems (including support equipment and production equipment) within our large-scale manufacturing facility. This includes qualifications of new support and production equipment, cleaning validation, participation in changes and Tech Transfers of new products. The department supports the existing production facility and is also supporting expansion projects . The Support equipment team is a part of the Validation department and consists of 15 validation engineers and 2 student helpers . We provide support for Chambers (Incubator s , Refrigerators , Freezers , Cold room , Warehouse), Environmental (HVAC, Cleanrooms, Clean Air Devices ), Utili ti es, Glasswashers and Autoclaves. We cover initial qualifications , re qualifications and performance qualifications . The working environment is built on trust, open communication with a strong focus on safety and respect for colleagues.

Application

If this sounds interesting for you, please upload your CV and Cover letter as soon as possible as we screen candidates on a continuous basis.

If you have questions, then feel free to reach out to the hiring manager Abdu Sahan on [email protected] .

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.