Responsible Engineer, Upstream Process Engineering

We have an exciting opportunity for an equipment responsible engineer within FUJIFILM Diosynth Biotechnologies located in Hillerød, Denmark. In this role, you will provide crucial support for clinical and commercial manufacturing of drug substance, improvements, quality/operational robustness/cost savings initiatives while ensuring compliance with cGMP, quality and safety standards for FDA regulated products.

You will be part of the Upstream Process Engineering team which is situated in the Engineering Support department. The overall responsibility of Upstream Process Engineering is to secure that the upstream manufacturing equipment is available for manufacturing when needed. The team consists of 6 responsible engineers.

The position interacts closely with the Drug Substance Manufacturing team as well as several engineering disciplines such as Quality, Automation, Validation, Process Science, Plant Engineering, Maintenance, and Project Engineering.

Responsibilities

  • Support the production and secure reliable and robust operations. Onsite support needs may occur in the evening and/or weekends and participation in the engineering on-call program is required on rotational basis.
  • On the floor presence and support after any critical process equipment changes.
  • Focus on operational robustness and cost efficiency in everyday work and processes. Drive, support, and perform assessment based on impact and effort for prioritization.
  • Drives equipment changes, specify and install new equipment, provides engineering technical support and troubleshooting for all cell culture equipment as required.
  • Review validation protocols and support validation testing.
  • Provides project engineering support as required for new processing equipment installations and modifications to existing equipment.
  • Participate in cross-functional teams to implement changes and / or improve existing processes.
  • Provide training as needed to ensure the production team understands equipment functionalities.
  • Communicate progress, status, and issues to stakeholders and upper management.

 

Requirements:

  • Minimum a Bachelor’s Degree within engineering or similar discipline.
  • A few years of experience in the areas of GMP manufacturing, engineering or facilities in a pharmaceutical environment.
  • Enjoy working as part of a team and also being comfortable working independently.
  • Experience working with Cell Culture equipment in a commercial environment is a big advantage.
  • Fluent in English both verbal and written.

 

If you need more information, please contact Esben Eggertsen, Manager Process Engineering, +45 41949739.

Please apply online in the HR system, applications received in other ways will not be considered. We are reviewing applications on 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 Teesside, UK, RTP, North Carolina, College Station, Texas and Hillerod, Denmark. FUJIFILM Diosynth Biotechnologies has over thirty years of experience in the development and manufacturing of recombinant proteins, vaccines, monoclonal antibodies, among other large molecules, viral products and medical countermeasures expressed in a wide array of microbial, mammalian, and host/virus systems. Delivering recombinant proteins, viral vaccines and gene therapies to patients requires commitment and partnership. We have become a trusted partner to some of the most prominent biotech developers and pharmaceutical companies in the industry where we are currently licensed for the commercial manufacture of 15 approved products.

Our manufacturing site in Hillerød, Denmark, brings together a complete range of expertise, capabilities and technologies to manufacture advanced biologics. Our large scale manufacturing facility has a capacity of 120,000 liters to reliably manufacture biologics for late phase and commercial use. The facility for medical device assembly, labeling and packaging manufactures advanced delivery systems and ensures required labeling and secure packaging of the therapies for patients worldwide. The site also houses quality control laboratories, warehouses, and a number of organizations, supporting the manufacturing activities: process science, supply chain management, engineering and quality assurance.

On June 9, 2020 FUJIFILM Corporation has announced the investment of approx. 6 billion Danish kroner into the site to double the manufacturing capacity, to add a fill finish capacity and to enhance the assembly, label and pack services on site. The investment is expected to create approx. 300 new jobs.

Our people are what make FUJIFILM Diosynth Biotechnologies standout. We recruit talented and passionate people, each playing a vital role in our success. At FUJIFILM Diosynth Biotechnologies, you will gain hands-on experience in an industry-leading biologics contract development and manufacturing organization. You will work with highly-skilled and experienced professionals of different nationalities and backgrounds, engaging in challenging work by delivering solutions for the biopharmaceutical industry.

We aim to foster a collaborative, innovative, diverse and rewarding environment, where it is possible to develop and learn. We pursue our fullest potential as individual contributors and team members. As part of our team, every one is a valuable contributor in the advancement of tomorrow’s medicine. We take pride in enriching our communities, caring for our environment, and cultivating a world of opportunity for future generations.


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