Commissioning, Qualification and Validation (CQV) Lead for Drug Product & Finished Goods

Are you our new Senior Validation Engineer, in our Commissioning, Qualification and Validation (CQV) team covering both Drug Product & Finished Goods? We are looking for a CQV Lead to support our increasing portfolio of customer programs at our site in Hillerød, Denmark.

Main responsibilities:

• Lead and execute risk-based validation across Drug Product (DP) and Finished Goods (FG), covering equipment, processes, utilities, and computerized/automation systems.
• Prepare/execute VPP/VFR, IQ/OQ/PQ, AVP/AVR for new/modified equipment and utilities.
• Act as Validation SME: define strategies, acceptance criteria, and lifecycle documentation aligned with site/global standards.
• Perform QMS activities in TrackWise (change controls, deviations, CAPAs), including investigations and effectiveness checks.
• Ensure ALCOA+ data integrity, inspection readiness, and support/lead FDA/EMA and customer audits.
• Collaborate with Automation/AI teams on compliant computerized/AI-enabled workflows.
• Key partner during inspections and audits.

Qualifications

Must-have:

• BS/MS in engineering or science (e.g., Chemical/Mechanical/Biotech Engineering, Pharmaceutical Science) or equivalent experience.
• 5–10+ years in biopharma validation/quality (DP/FG).
• Expertise in equipment/process/utility qualification; DP areas such as formulation, filling, cleanrooms, sterilization.
• Strong cGMP and risk-based validation knowledge; QMS tools (TrackWise).
• Excellent technical writing/communication; cross-functional collaboration skills.

Nice-to-have:

• Experience with AI-enabled systems to improve CQV compliantly.
• Knowledge of FDA/EMA/ICH, EU Annex 15, ASTM E2500, GAMP 5; risk tools (FMEA, HACCP).
• Aseptic/cleanroom and multiproduct/multiline experience.
• URS/FAT/SAT/commissioning and ALCOA+ experience.
Stats for validation (sampling plans, capability); MS Office proficiency

About the department and the team
We are a very diverse team at many levels and have an open & honest tone and approach to everyday challenges.
The work environment is international and informal. We keep a high pace and focus on a vital work balance while having fun. We put a strong emphasis on psychological safety through trust and empowerment within our teams and hope that this is something that speaks to you as well.

Your application

Please upload your CV and cover letter in English as soon as possible, and latest by July 10th. Please be aware that there can be a delay in response due to summer vacation.

For more information about the open position, please contact Mikkel Larsen, Director at +45 31326343.

Working at FUJIFILM Biotechnologies

We offer a competitive compensation package in a site/company growing rapidly, with many opportunities for individual growth, we also offer access to fitness and an attractive canteen.

FUJIFILM Biotechnologies is an industry-leading Biologics Contract Development and Manufacturing Organization (CDMO) with locations in Hillerød, Denmark, Teesside, UK, RTP, North Carolina and College Station, Texas, USA. We use our skills, dedication and ambition to enable impact for the world’s most innovative biotech and biopharma companies reimagining healthcare’s potential. We work across the entire lifecycle of our customers’ products – enabling success throughout. Every cure, vaccine, biologic, and advancement we contribute to starts with our people and our passion. We fuel one another’s passion, help accelerate progress, expand capabilities, strengthen innovation, and improve processes to improve lives.

Our Manufacturing site in Hillerød, Denmark, brings together a complete range of expertise, capabilities and technologies to manufacture advanced biologics. As we continue to enhance and expand our capabilities, we are looking for people who share our passion, drive, and energy – what we call Genki – to join our team.

We offer the chance to be part of a global workplace where passion, drive and commitment are met with opportunities for professional and personal development. Deeply committed to diversity and inclusion, we ensure that everyone no matter their background or gender has an opportunity to develop. We take pride in enriching our communities, caring for our environment, and cultivating a world of opportunity for future generations.

We aim to foster a collaborative, innovative and rewarding environment, where diverse perspectives and people come together united by a common purpose and shared values. We pursue our fullest potential as individual contributors and team members. We strive to be the employer of choice and offer a competitive compensation and benefit package.

FUJIFILM Biotechnologies 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 identify 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 in any form and/or method will be deemed the sole property of FUJIFILM, unless such search firms/employment agencies were engaged by FUJIFILM for this requisition and a valid agreement with FUJIFILM is in place. In the event a candidate who was submitted outside of the FUJIFILM agency engagement process is hired, no fee or payment of any kind will be paid.