Validation Engineer / Validation SME for our Controlled Temperature Units

FUJIFILM Diosynth Biotechnologies; Hillerød; On-site; DKK 900,000 - 1,200,000; Full time

Benefits offered by this job

Fitness facilities

Canteen

Career growth opportunities

Job summary

FUJIFILM Biotechnologies Denmark (FLBD) is seeking an experienced Validation Engineer / Validation SME to drive CTU validation activities across refrigerators, freezers, cold rooms, and related equipment. The role requires deep regulatory knowledge and strategic direction for qualification and validation programs.

You will act as validation SME, lead CQV activities, support inspections, and ensure compliance with global regulatory requirements while enabling operations and expansion projects at

Qualifications

• 8+ years of CTU validation experience in pharma/biotech.
• Experience qualifying CTUs and production equipment.
• Strong IQ/OQ and CQV experience.
• Knowledge of EU GMP Annex 1/15, ICH and FDA regs.
• Experience supporting regulatory inspections and observations.

Responsibilities

• Serve as Validation SME for one type of CTU (Refrigerators).
• Own validation program for CTUs and lifecycle.
• Lead validation activities including IQ, OQ, PQ, and lifecycle verification.
• Support customer audits and regulatory inspections.
• Drive inspection readiness and remediate audit findings.
• Develop validation strategies and risk-based approaches.
• Maintain validated state of CTUs throughout their lifecycle.
• Collaborate with cross-functional teams and stakeholders.

Skills

Validation SME

Regulatory knowledge

Stakeholder management

Autonomy

Education

Bachelor’s / Master’s in Engineering or Life Sciences

Tools

IQ/OQ

Requalification

CQV

Quality Risk Management

Change Control

Deviations

Investigations

CAPAs

Job description

FUJIFILM Biotechnologies (FLBD) is seeking an experienced Validation Engineer / Validation Subject Matter Expert (SME) to drive validation activities related to Controlled Temperature Units (CTUs) including Refrigerator, Freezer, Cold room, Warehouse and Incubator.

This is a highly visible role requiring deep technical expertise, strong regulatory knowledge, and the ability to provide strategic direction for qualification and validation activities for CTUs. The successful candidate will act as validation SME within the area and play a key role in ensuring compliance with global regulatory requirements while supporting ongoing operations, expansion projects, and inspection readiness.

Main Responsibilities

• Serve as Validation SME for one type of CTU (Refrigerators)

• Technical ownership of the validation program for CTUs

• Act as validation SME during customer audits & regulatory agency inspections.

• Drive inspection readiness activities and support remediation of audit observations and regulatory commitments

• Decision-making authority on validation strategy and risk-based approaches

• Own and maintain the validation strategy and validated state for CTUs throughout their lifecycle

• Lead and approve validation activities including Commissioning & Qualification Strategies, Quality Risk Assessments, IQ, OQ, RQ, and Continued Lifecycle Verification

• Lead Quality Risk Assessments and impact assessments related to deviations, CAPAs, change controls, investigations, and system improvements.

Qualifications

• Bachelor's, Master's, or equivalent degree within Engineering, Biotechnology, Pharmaceutical Sciences, or a related discipline.

• At least 8+ years of relevant CTU and validation experience within pharmaceutical, biotechnology, or life science industries.

• Extensive experience qualifying and maintaining CTUs and other production equipment.

• Strong experience with IQ/OQ, Requalification programs, Quality Risk Management, Change Control, Deviations, Investigations, CAPAs, and Commissioning, Qualification & Validation (CQV).

• Proven experience developing validation strategies and lifecycle approaches for complex GMP systems.

• Deep knowledge of EU GMP Annex 1, EU GMP Annex 15, ICH Q8/Q9/Q10, ISPE Guidance, ISO 14644 cleanroom standards, ASTM E2500, GAMP Principles, FDA regulations, and regulatory requirements.

• Demonstrated experience supporting regulatory inspections and responding to observations from health authorities and customers.

Personal Skills

• Confident in challenging technical decisions and influencing stakeholders.

• Pragmatic, solution-oriented, and capable of balancing compliance with business needs.

• Self-driven and comfortable operating with a high degree of autonomy.

• Skilled at creating structure, establishing priorities, and driving execution.

• Able to manage multiple critical activities simultaneously and deliver to demanding timelines.

• Comfortable working across all organizational levels.

• Respected for technical credibility, professionalism, collaboration and stakeholder management.

• Passionate about quality, compliance, and continuous improvement.

The team / department

The Validation department is responsible for maintaining the validated state of Facility, Utility and Equipment Systems (including support equipment and production equipment) within our large-scale manufacturing facility. This includes qualifications of new support and production equipment, cleaning validation, participation in changes and Tech Transfers of new products. The department supports the existing production facility and is also supporting expansion projects.
The Support equipment team is a part of the Validation department and consists of 16 validation engineers and 2 student helpers. We provide support for CTUs (Incubators, Refrigerators, Freezers, Cold room, Warehouse), Environmental (HVAC, Cleanrooms, Clean Air Devices), Utilities, Glasswashers and Autoclaves. We cover initial qualifications, requalifications and performance qualifications.
The working environment is built on trust, open communication with a strong focus on safety and respect for colleagues.

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.

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 identify or any other protected class.

Location:

Hillerod

If you have questions, then feel free to reach out to the hiring manager Abdu Sahan on [e-mail].