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Process Supporter

FUJIFILM Diosynth Biotechnologies


Hillerød, Denmark
We are looking for a Process Supporter to join the Drug Substance Manufacturing Project & Support team. You will be part of a team of 9 dedicated employees who execute Opex projects and deliver general support to the Drug Substance Manufacturing organisation (DSM).

The role
In the role as Process Supporter you are responsible for executing various Opex tasks in different departments, supporting the following; MES systems, deviation handling, procedure updates and failure investigation in close collaboration with QA functions other departments.

Delivering support to manufacturing covers ongoing support to MES systems, manufacturing optimization tasks and executing Opex projects. Opex projects comprises replacement, change or introduction of new DSM equipment. This is followed by thorough technical review and assessment of equipment impact on manufacturing processes and change control procedures.

Main responsibilities:

  • Execute Opex projects in different departments across DSM
  • Troubleshooting of challenges in MES systems together with IT/Automation.
  • Defining tasks and projects through URS description or similar with DSM departments.
  • Support with technical knowledge for updating and changes of general documents in DSM
  • Perform EHS tasks, CAPA work and review of validation protocols.
  • Introduction of new manufacturing equipment, items and procedures in DSM.
  • Planning and supporting change control.
  • Ongoing support and participation in Site Capex projects.

Qualifications and Education

  • You have a Bachelor or Master Degree within Engineering, Pharmacy or similar and a minimum of 5-10 years relevant working experience.
  • You are an experienced Engineer or similar with analytical skills and project supporter mindset. You have a successful track record in delivering Opex task in a manufacturing environment. You are used to work closely with manufacturing MES systems and GMP IT systems.
  • In delivering your work and results you have gained experience and knowledge of databases, tools and systems (MS Project, Excel etc.) and solid experience in the execution of projects.
  • Thorough understanding and ability to execute against regulatory compliance parameters and solid and in-depth experience with GMP.
  • Excellent English skills verbally and in writing and excellent oral and written communication skills, as you must be able to work cross-functional with multiple stakeholders.
  • As a person you have a strong sense of urgency about solving problems, prioritizing and getting work done. You have good energy, you are proactive and you enjoy working in a dynamic and innovative environment with changing priorities.

For more questions about the position, please contact William Herrmans, Project Manager Mfg Support on 81929161.

Application
Please upload your CV and cover letter as soon as possible. We are reviewing applications on a continuous basis and urge you to apply as soon as possible.

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 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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Biogen Alle 1
3400 Hillerød
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