Validation Engineer

FujiFilm; Hillerød; On-site; DKK 520,000 - 760,000; Full time

Benefits offered by this job

Fitness access

Canteen

Job summary

FUJIFILM Diosynth Biotechnologies Denmark (FDBD) in Hillerød is expanding its Validation team. We seek a driven Validation Engineer to qualify downstream processes and support PPQ and capex changes.

You will write IQ/OQ/PQ protocols, review reports, and document validation activities while ensuring readiness for audits and inspections. The role requires a Bachelor's or higher in Engineering, 3-5 years in validation, and strong technical writing plus cross-functional collaboration with

Qualifications

• Bachelor's or higher degree in Engineering or a relevant discipline.
• 3-5 years of industry experience in validation.
• Experience with IQ/OQ/PQ protocols and reports.
• Ability to write and review validation documentation.

Responsibilities

• Participate in PPQs and capex changes.
• Write and review IQ, OQ, PQ protocols and reports.
• Plan and execute cleaning validation and validation procedures.
• Support audits and inspections.

Skills

Validation execution

Risk-based approach

Technical writing

Strong communication

Team player

Hands-on

Independent/adaptable

Education

Bachelor's or higher in Engineering or relevant discipline

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:Risk based qualification of downstream process equipmentMicrobial hold time validationPrevious experience from projects and qualificationMain 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 are not limited to):Write and review IQ, OQ and PQ protocols and write reportsParticipate in and assess change controlsPlan and prepare executionsPlan, prepare, execute, and document all phases of cleaning validationWrite and update validation procedures and technical documentsParticipate in audits and inspectionsQualifications: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 teamThe 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.Your applicationFor more information about the open position, please contact Martin Therkelsen, Manager Validation. Please upload your CV and Cover Letter in English as soon as possible as we screen candidates on a continuous basis. The Job Ad will be removed when the right candidate has been identified.Working at FUJIFILM Diosynth BiotechnologiesWe 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. We strive to be the employer of choice and offer a competitive compensation and benefit package.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.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.