Manufacturing Associates (Process Operators) to support the expansion

Manufacturing Associates (Process Operators) to support the expansion project

FUJIFILM Biotechnologies is seeking Manufacturing Associates (Process Operators) for the Drug Substance Manufacturing Unit in Hillerød to support an ambitious expansion project. This initiative will significantly enhance our production capacity by adding 8 x 20,000L bioreactors and two downstream processing lines, establishing the facility as the largest end-to-end CDMO in Europe. With a total of 20 x 20,000L bioreactors for drug substance production, complemented by comprehensive drug product and finished goods services, we are poised to lead the industry in scale and innovation.

The Role:

Embark on an incredible journey with us as we launch a new production line, fostering a culture of excellence and quality to deliver high-impact results for customers and patients worldwide. This is your chance to innovate in a dynamic start-up environment, distinct from traditional manufacturing, as you commission cutting-edge equipment and develop vital processes. Take the lead in creating work instructions, turning initial drafts into finalized documentation that sets the standards for our future. Upon completion of the project, you will transition into a permanent Manufacturing Associate role in one of our production departments—Upstream, Downstream, or Solution Preparation—working within a day or night shift schedule. Join us at this pivotal moment of growth and be part of an inspiring adventure that shapes the future of global healthcare.

Responsibilities:

We are seeking candidates to drive our expansion by:

Setting up and testing equipment during commissioning and qualification.

Collaborating closely with validation teams and external contractors to execute Process Qualification.

Review technical documents like drawings, data sheets and work instructions.

Joining daily, weekly and monthly project meetings and walkdowns.

Reviewing and executing PQ protocols and work instructions.

Providing troubleshooting support during PQ and start-up activities.

Work Schedule:

Initial Period (approx. first 6-7 months): Monday to Friday, regular office hours.

Progression: Flexibility may be required as tasks may occur during evenings or nights.

Post-initial period: You will transition to a fixed shift schedule (either day or night) in a permanent Manufacturing Associate role within one of our production departments – Upstream, Downstream, or Solution Preparation.

Shift Details in post-initial period:

Day 1: 06.00 – 17.49

Day 2: 07.45 – 18.49

Night 1: 18.30 – 04.45

Night 2: 20.05 – 06.00

Weekly Rotation:

Week 1: Monday, Tuesday, Friday, Saturday, and Sunday

Week 2: Wednesday and Thursday

Please indicate your preferred shift in your application for post-project scheduling.

What you will gain from being part of the project:

Project Development: Get hands-on experience in shaping a new production from set-up to go live

Equipment Expertise: Learn to operate and troubleshoot new equipment during installation and qualification.

Documentation Skills: Support the creation of SOPs and validation protocols for a brand-new facility. protocols.

Collaborative Engagement: Work cross-functionally with project, validation, and engineering team.

Problem-Solving: Be part of solving real time issues during start-up and ramp-up phases.

Adaptability: Build resilience in managing change and overcoming unexpected challenges.

Cultural Enrichment: Join a diverse, international project team.

All of the skills you develop on the project will be transferable and invaluable once you transition into a permanent Manufacturing Associate role.

What we expect from you:

Technical Acumen: You have hands-on experience in a pharmaceutical or similar regulated production environment. You bring solid GMP knowledge and are confident working with manufacturing equipment and documentation processes. Alternatively, you’re a life science graduate and eager to apply yout knowledge in a practical production setting.

Hands-on mindset: You’re ready to support setting up a new manufacturing facility from scratch.

Multitasking: You manage changing tasks and priorities during a dynamic project phase.

Proactive Attitude: You’re curious and ready to take initiative in a start-up setting where processes are still being shaped.

Collaboration: You contribute to a team where knowledge sharing and joint problem-solving are essential.

Adaptability: Things will change quickly - you thrive in a dynamic set up where processes are still being established.

Communication: You communicate clearly and professionally in English, especially when documenting or coordinating work.

If you are as excited as we are and believe this is the right opportunity for you, please submit your CV and motivation letter as soon as possible as we will have ongoing interviews finding the right candidates.

It is a requirement for being considered for an interview that CV and motivation letter is in English.

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 site in Hillerød, Denmark, brings together expertise, capabilities and technologies to manufacture advanced biologics. The large scale manufacturing facility has a capacity of 120,000 liters to reliably manufacture biologics for late phase and commercial use. We commenced 6 billion DKK projects to double our manufacturing capacity and to add fill finish to the site.

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.

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.

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.

JR4938