Validation Engineer

FLBD FUJIFILM Life Sciences Biotechnologies Denmark ApS; Hillerød; On-site; DKK 650,000 - 850,000; Full time

Job summary

FUJIFILM Diosynth Biotechnologies Denmark (FDBD) in Hillerød is seeking a Validation Engineer to join the downstream validation team. You will contribute to risk-based qualification of downstream equipment, participate in PPQs, and help ensure equipment readiness for production while supporting audits and inspections.

You will writeIQ/OQ/PQ protocols, review reports, and plan validation activities across all phases.

Qualifications

• Bachelor's or higher degree in Engineering or a relevant discipline with 3–5 years of industry experience.
• Knowledge of industry practices, practical experience, and a keen interest in hands‑on validation execution.
• Lean working methods and a risk-based approach to deliver efficient qualifications.
• Strong technical writing and communication skills to articulate complex information to stakeholders.
• Team player who thrives in collaboration and cross‑functional teams.
• Independent, adaptable, and dynamic in approach to work.

Responsibilities

• Write and review IQ, OQ and PQ protocols and write reports.
• Participate in PPQs and capex changes.
• Plan and prepare executions and validate cleaning processes.
• Plan, prepare, execute, and document all phases of validation.
• Write and update validation procedures and technical documents.
• Participate in audits and inspections.

Skills

Risk based qualification

Validation execution

Technical writing

Communication skills

Team player

Independent/adaptable

Education

Bachelor's or higher in Engineering

Job description

Ready for your next challenge in validation?

Fujifilm Diosynth Biotechnologies (FDB) in Hillerød is growing—and we’re expanding our equipment and systems. We’re hiring passionate, driven Validation Engineers to help us scale. Join our Downstream team as a Validation Engineer if you have experience in one or more of the following:

Required experience

• Risk based qualification of downstream process equipment
• Microbial hold time validation
• Previous experience from projects and qualification

Main Responsibilities

• As part of the validation team, you will participate in PPQs and capex changes.
• You will be part of ensuring equipment is ready for running production and participating in audits and inspections.

Additional Tasks (include but not limited to)

• Write and review IQ, OQ and PQ protocols and write reports
• Participate in and assess change controls
• Plan and prepare executions
• Plan, prepare, execute, and document all phases of cleaning validation
• Write and update validation procedures and technical documents
• Participate in audits and inspections

Qualifications

• You hold a Bachelor's or higher degree in Engineering or a relevant discipline, with at least 3-5 years of industry experience.
• You possess knowledge of industry practices, practical experience, and a keen interest in hands‑on validation execution.
• You are aware of lean working methods and can apply a risk‑based approach to deliver efficient qualifications.
• Strong technical writing and excellent communication skills are essential, as you will need to articulate complex information to stakeholders such as Engineering, QC, QA, Manufacturing, Automation, Maintenance, and Process Science.
• You are a team player who thrives in collaboration and cross‑functional teams.
• You bring a friendly, can‑do attitude, professionalism, and a good sense of humor.
• You are independent, adaptable, and have a dynamic approach to work.

About the department and the team

The Validation team has the responsibility of ensuring the validated state of the running production systems within the large-scale manufacturing drug substance facility. The team is divided in upstream and downstream and they participate in tech transfer of products, qualification of new equipment and modifications as well as in larger projects. We have good sense of humor in the team, and we are good at helping each other. We are good at integrating new hires into the team and give a thorough introduction to our systems. There are also a lot of social events within the department.

Working at FUJIFILM Diosynth 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 Diosynth 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.

Competitive compensation and benefits package

We strive to be the employer of choice and offer a competitive compensation and benefit package.

Equal Opportunity Employer

FUJIFILM Diosynth 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.