IT/OT Quality Specialist – 6 Month Paternity Leave Cover

Fujifilm; Hillerød; On-site; DKK 600,000 - 800,000; Full time

Benefits offered by this job

Fitness access

Canteen

Job summary

FUJIFILM Biotechnologies Denmark is seeking an IT/OT Quality Specialist to support a global initiative developing SOPs, WIs and templates across IT/CSV. The role requires validating computerized systems in a GMP environment and collaborating with global partners to ensure data integrity.

The position is based in Hillerød, Denmark, for a 6-month paternity cover. You will engage with local SMEs and QAs, facilitate trainings, and help establish new processes in a dynamic, fast-paced setting.

Qualifications

• Solid GMP/GxP knowledge and experience with validation across GxP systems.
• Familiarity with 21 CFR Part 11, Eudralex Annex 11, and Data Integrity.
• Experience writing and reviewing SOPs, WIs and templates for IT/CSV processes.
• Strong communication and collaboration across global partners.

Responsibilities

• Collaborate with global IT, CSV and Quality teams to write and review SOPs, WIs and templates.
• Support local SMEs and QAs in reviewing or consolidating SOPs and WIs for computerized systems.
• Lead or facilitate sessions explaining new processes to IT/OT QAs.

Skills

GxP knowledge

GMP regulations

GAMP5

ITIL

Communication

Collaborative mindset

Self-driven

English fluency

Job description

Do you have experience with computer system validation (CSV) and lifecycle activities across GxP areas and do you have the ability to work in a very dynamic environment with a clear sense and 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 for a 6-month paternity leave cover, starting 1 January 2027, in the QA Digital Technologies team based in Hillerød, Denmark.About the DepartmentThe QA Digital Technologies (QADT) team is growing and currently exists of 13 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 PositionYou will support a global initiative to develop a package of global SOPs, work instructions and templates supporting processes across the IT organizationThe tasks will include:Collaborating with global IT, CSV and Quality partners in writing and reviewing global SOPs, WIs and templatesSupporting local SMEs and QAs in review or consolidation of existing local SOPs and WIs for computerized systemsFacilitating sessions explaining new processes to other IT/OT QAsQualificationsWell-versed in GMP regulations/processes, including 21 CFR Part 11, Eudralex Annex 11 and Data Integrity.Knowledge of IT and CSV methodologies, including GAMP5 and ITIL.Collaborative mindset with a willingness to integrate oneself in the team and organisationMinimum 5 years of work experience or educational background that allows for understanding of the complexity of computerized system validation across GxP systems.Minimum 1 year of work experience in writing procedural documents for GxP processes.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 structureSpeak and write English fluentlyYour ApplicationThis is a 6-month paternity leave cover starting 1 January 2027.Please upload your CV and cover letter as soon as possible. We review applications on an ongoing basis and will close the position once the right candidate has been found.Working at FUJIFILM 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 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 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 identity, 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.