IT/OT Quality Specialist

Do you have experience with computer system validation and lifecycle activities across GxP areas and do you have the ability to work in a very dynamic environment with a clear sense of high pace? Do you bring loads of energy and thrive to work with a broad range of stakeholders? Then you might be the person we are looking for!

We are currently looking for an IT/OT Quality Specialist to join the QA Digital Technologies team based in Hillerød, Denmark.

About the Department

The QA Digital Technologies (QADT) team includes 12 colleagues with lots of energy. Our culture is all about collaboration and dialogue. As a member of the QA Digital Technologies (QADT) team, you will not only become part of a fantastic team, but also become part of a QA team partnering with our global IT department and local Automation team together with a broad range of stakeholders throughout the Hillerød Site as well as globally.

About the Position

You will take part in projects implementing and/or upgrading computer systems, lifecycle activities, and contribute to global QA alignment on CSV and lifecycle tasks. Furthermore, you will be an important contributor in the continuous development and maintenance of the quality systems related to IT and Automation based on current GMP and regulatory requirements.

Your primary responsibilities will include but not be limited to:

• Perform QA support to IT and Automation on CSV matters; review and approve system development and life cycle artefacts, validation and change control documentation for computerized systems supporting GxP processes.

• Ensure procedures and methodologies are followed, and that appropriate and complete documentation is captured and reported. Act as quality partner by providing guidance, training and ad hoc support to stakeholders herewith.

• Represent QADT on assigned computerized systems projects.

• Employ risk-based methodology and support, develop and implement validation strategies for computer systems – also focusing on business processes and data integrity.

• Take part in local and global alignment tasks within IT quality and CSV.

• Maintain internal training level and keep up to date on cGMPs and regulatory requirements as well as on global procedures, guidelines, policies, frames, and specifications.

Qualifications

• Collaborative mindset with a willingness to integrate oneself into the team and organisation
• 3-5 years of work experience or educational background that allows for understanding of the complexity of manufacturing biologics

• Well-versed in GxP guidance, including 21 CFR Part 11, Annex 11 and Data Integrity

• Knowledge of IT Controls methodologies, including GAMP5 and ITIL.

• Experience with computerized system validation across GxP systems.

• Ability to work in a very dynamic environment and thrive building the road as we go.

• Self-driven, excellent communication skills and good at creating structure

• Speak and write English fluently

Educational Qualifications

The right mindset, strong deliverables and practical experience are key. Educational background comes second, but could be within the following areas (though not a prerequisite): Bachelor or Master of Science in IT or natural science, e.g., Pharmacy, Biotechnology, Biology, Engineering or similar.

Your Application

If you are as excited as we are and believe this is the right opportunity for you, please submit your CV and motivational letter in English as soon as possible as we will take down the advert when we have identified the right candidate.  

For questions or doubts, please do not hesitate to contact Manager in Quality Assurance Tine Dam-Andersen on tine.dam-andersen@fujifilm.com

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. 

FUJIFILM Biotechnologies Denmark (FLBD) 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.