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 is growing. Currently we are 9 colleagues with lots of energy and genki. Our culture is all about collaboration and dialog. 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 in 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 is key. Educational background comes second, but could be within the following areas (thought not 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 [email protected]

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. 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.

Location: FDBD Hillerod