CQV Lead for Aseptic Filling Manufacturing

Would you like to design validation strategies and collaborate with CAPEX and Tech Transfer Project Managers to enhance project execution?

And could you coordinate with lead contractors to effectively validate equipment packages for complex projects?

Then we hope you are our new CQV Lead colleague!
 

Your New Role

You will design validation strategies and liaise with Operations and MSAT to execute on the strategy. The primary scope is equipment used in the DP manufacturing suite. Secondary scope is rooms and operational processes.

Main Tasks:

• Creating, executing on Validation Plan for equipment in scope.
• Maintaining the validated state and assessing changes against the validated state.
• Execute, monitor, and track CQV activities of equipment in scope as part of projects or Operations activities.
• Act as Functional lead (no direct references) of CQV contractors.
• Provide technical expertise on validation activities as SME for GMP events or project activities.
• Create reports in relevant IT systems, create and drive Change controls, assessments, investigations, or CAPAs related to field in scope.
• Present relevant validation activities and documents to Health authorities.

Your Skills & Talent:

• +6 years’ experience as CQV engineer.
• Strong experience in Aseptic Filling, cleaning validations and/or Fill Finish
• Strong Knowledge of Validation and Risk Assessment of manufacturing equipment in GMP
• Strong knowledge of Annex 1,15, ASTM E2500, ICH Q9, Quality By Design and relevant ISO standards related to Aseptic Manufacturing

We Hope you are

A structured and can-do team player with a keen eye for timelines while thriving in a very dynamic environment

Your New Team & Department

DP MSAT covers a broad scope and play a central part in Drug Product Manufacturing. Our team is composed of process owners, responsible engineers, technology specialists, CQV leads and Pilot laboratory scientists.

We are in expansion phase as we get closer to clinical and commercial drug product manufacturing operations starting early 2026.
 
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.

Application

Has this sparked your interest, then please upload your CV and cover letter as soon as possible, as we screen candidates on a continuous basis and call in for interviews. If you have any questions, do not hesitate to reach out to the hiring manager Frédéric Osuch +45 20723569

FUJIFILM Biotechnologies is a global leader in biologics contract development and manufacturing Organization (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://fujifilmbiotechnologies.fujifilm.com/

FUJIFILM Biotechnologies Denmark 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.