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Validation Engineers

FUJIFILM Diosynth Biotechnologies


Hillerød, Denmark
The Hillerød Validation & Engineering support team is looking for Validation Engineers who will complement the current capabilities of the team and participate in daily operations and expansion and improvement projects.

You will be part of the Engineering Support department where you will be responsible for maintaining the validated state of equipment and systems within the Drug Substance Manufacturing area. This includes qualification of new and modified equipment, utilities, chambers, autoclaves, sterilization and cleaning validation, problem solving and participation in projects, changes and investigations.

Main responsibilities

  • Planning and participation in key projects with validation impact
  • Preparing, performing and documenting commissioning, IQ, OQ and PQ activities
  • Participating and executing in change controls
  • Planning, executing and documenting all phases of cleaning validation
  • Preparation of annual validation planning / reporting documents for product campaigns
  • Participation in audits and inspections, answering regulatory requests

As the CDMO business at the Hillerød site expands, the Validation team anticipates increased complexity including new processes and a more diverse product portfolio. Candidates with experience and broad knowledge of both equipment and validation are therefore preferred.

Qualifications
You hold a Bachelors or higher degree in Engineering or other relevant discipline, and have at least 8 years of relevant industry experience.

You have demonstrated knowledge of industry practices and current trends and possess practical experience and interest in hands-on validation execution. You are conscious of lean ways of working and able to apply a risk-based approach to deliver efficient qualification.

For this role you need to have strong technical writing and excellent communication skills, as you will have to articulate complex information to stakeholders such as Engineering, QC, QA, Manufacturing, Automation, Maintenance, etc.

You are a team player who enjoys working well with colleagues and in cross-functional teams. As a person you bring a friendly, can-do demeanour, professionalism and a good sense of humour. You are self-starting and have a flexible, dynamic approach to work.

Please apply as soon as possible as we handle applications on a continuous basis.

APPLY

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
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.



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FUJIFILM Diosynth Biotechnologies - hurtigt overblik


Placering
Biogen Alle 1
3400 Hillerød
Logo: FUJIFILM Diosynth Biotechnologies
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