Temperature-Controlled Equipment Engineer (GxP/GMP)

Do you wish to become part of a fast-growing global CDMO company? Do you want to put your theoretical knowledge into practice? Then our Temperature-Controlled Equipment Engineer role within Engineering & Facilities (E&F) in Hillerød might be the right choice for you!

About the position
We’re seeking a Temperature-Controlled Equipment Engineer to be the technical owner for temperature-controlled units (CTUs)—refrigerators, freezers (incl. ULT), and incubators—supporting critical GxP operations in a GMP environment. You will be accountable for CTU strategy, delivery, and day-to-day reliability, owning lifecycle management, integrations with monitoring systems, change and configuration control, auditability, and regulatory compliance.

In this role
you will partner with cross-functional stakeholders (Production, QA/Quality Systems, Validation, Facilities/Utilities, EHS, IT/Infrastructure, and external vendors) to deliver compliant, reliable, and highly available equipment that safeguards product quality. You’ll drive full-lifecycle projects from URS and vendor selection through FAT/SAT, installation and commissioning to qualification, handover, and sustainment—maintaining the roadmap and budgets and ensuring that governance and SOPs translate into practical, well-documented operations.

You will be a part of E&F and collaborate closely with colleagues across Engineering, Validation, and Operations.

Key responsibilities (not limited to)

• Serve as the SME and system/equipment owner for CTUs: pharmaceutical refrigerators, freezers (incl. ULT), and CO₂/ambient incubators.
• Lead and close deviations, investigations, and CAPAs; perform root cause analysis and implement sustainable corrective and preventive actions.
• Plan and coordinate installation of new CTUs end-to-end (URS, vendor selection, FAT/SAT, delivery, utilities, commissioning/turnover).
• Optimize placement within the facility with a focus on user needs, material/personnel flows, utilities, heat loads, and compliance.
• Drive qualification and validation activities (IQ/OQ/PQ): author protocols, execute testing, review data, and issue final reports.
• Oversee temperature mapping studies, alarm verification/notification strategies, and setpoint/limit justifications; ensure ALCOA+ data integrity.
• Manage change control throughout the equipment lifecycle (introduction, upgrades, decommissioning) and support periodic review/requalification.
• Coordinate vendor service, preventive maintenance, and calibration; maintain CMMS and ensure GDP-compliant documentation.
• Ensure system/equipment health and audit readiness; support internal/external audits and inspections in alignment with GMP/GxP and guidelines (e.g., EU GMP, Annex 11/15, 21 CFR Part 11 as applicable).
• Champion safe operations in collaboration with EHS (e.g., refrigerants, CO₂ handling) and continuous improvement in reliability and energy performance.

What we are looking for The ideal candidate has

• Bachelor’s or Master’s degree in Engineering (Mechanical, Electrical, Chemical, Biomedical, or related) or equivalent experience.
• Hands-on experience in GMP/GxP pharma/biotech operations (facility, validation, or equipment engineering).
• Proven experience leading deviations/CAPAs, qualification/validation (IQ/OQ/PQ), temperature mapping, and controlled environment monitoring.
• Strong technical understanding of refrigeration and thermal control (compressors, condensers, evaporators, defrost strategies, insulation, thermal load management).
• Experience with change control, risk assessments (e.g., FMEA), and Good Documentation Practice; audit-ready mindset.
• Demonstrated vendor and contract management experience.

The ideal technical skills

• Understanding of monitoring/EMS/SCADA systems, data integrity practices, and applicable computerized system compliance (Annex 11/21 CFR Part 11).
• Experience with alarm strategies, setpoint/limit management, and data review/trending; comfort with scripting/automation is a plus.
• Familiarity with Windows-based systems, networking basics, and database-backed monitoring platforms.
• Deep experience with ULT freezers, pharmaceutical-grade refrigerators, and CO₂/ambient incubators is an advantage.

The ideal project management skills

• Ability to lead cross-functional teams, manage competing priorities, and deliver complex equipment programs from URS through handover.
• Excellent documentation, communication, and stakeholder management skills.
• Relevant certifications (e.g., PMP, Six Sigma, CETA) are a plus.

Your New Department
As a member of Engineering & Facilities at FUJIFILM Biotechnologies, you will report to the department’s leadership within Engineering/Utilities.

Engineering & Facilities is entrusted with equipment lifecycle management, utilities and facility reliability, qualification/validation support, and GMP compliance across our site.

We collaborate across the entire campus—closely with Production, QA, Validation, EHS, and Facility Management—to ensure the safety, efficiency, GxP compliance, and continuous growth of our operations.

E&F has an exceptional camaraderie. Despite the department’s commitment to diligent and focused work, there is always time for friendly conversations and shared laughter, fostering a positive and enjoyable working environment. Some tasks and projects can be a new way of working, so we are looking for a new colleague with the right “can do” attitude.

Application

Does this sound like you? Then please submit your CV and a motivated application no later than 31.05.2026 as we will be interviewing on an ongoing basis—please submit sooner rather than later.

Working at FUJIFILM 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 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

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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.