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Responsible Engineers, Upstream Process Engineering, Hillerød, Denmark

FUJIFILM Diosynth Biotechnologies located in Hillerød, Denmark, is expanding.

Therefore we have two new positions as equipment responsible engineers. 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 12 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.
  • Support tech transfer activities of new processes from customers to the production site in Hillerød
  • 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 supports 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 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.
  • 5+ 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. 

Please upload your CV and cover letter as soon as possible as we will screen candidates on a continuous basis:

https://fujifilmdiosynth.wd3.myworkdayjobs.com/en-US/External/details/Responsible-Engineers--Upstream-Process-Engineering_JR1396

For more information about the job please contact Esben Eggertsen, Manager Process Engineering at +45 41949739

 

About FUJIFILM Diosynth Biotechnologies

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 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.

www.fujifilmdiosynth.com

 

 

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Responsible Engineers, Upstream Process Engineering, Hillerød, Denmark

FUJIFILM Diosynth Biotechnologies located in Hillerød, Denmark, is expanding.

Therefore we have two new positions as equipment responsible engineers. 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 12 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.
  • Support tech transfer activities of new processes from customers to the production site in Hillerød
  • 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 supports 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 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.
  • 5+ 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. 

Please upload your CV and cover letter as soon as possible as we will screen candidates on a continuous basis:

https://fujifilmdiosynth.wd3.myworkdayjobs.com/en-US/External/details/Responsible-Engineers--Upstream-Process-Engineering_JR1396

For more information about the job please contact Esben Eggertsen, Manager Process Engineering at +45 41949739

 

About FUJIFILM Diosynth Biotechnologies

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 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.

www.fujifilmdiosynth.com

 

 

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