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Validation Engineer - Thermal validation, Hillerød, Denmark

Do you want to join an advanced biotech company that develops and manufactures some of the leading biological products on the market today and for the future? Then join FUJIFILM Diosynth Biotechnologies in Hillerød (FDBD), a biotech company that aspires to be the leading CDMO within our areas of expertise. 

We are looking for the right Validation Engineer or a candidate with experience as Validation Technician to the Chamber Validation team.

About the Department

The Chamber validation team is a part of the larger Validation department, responsible for equipment qualification and cleaning validation. The department is supporting the existing production facility but is also involved in the large expansion project where we are doubling the production capacity. The department will over the coming year grow in tact with the finalizing the new part of the factory.

About the Team you join and your Role 

The Chamber validation team consists of 3-4 people. The chamber validation team is responsible for validating and re-validation of freezers, refrigerators, incubators, and controlled rooms. You will be in contact with many different departments, such as QA, QC laboratories, Engineering, production, and warehouse in the Hillerød Facility. Your daily work will be a combination of setting up probes for temperature logging, data evaluation, preparing validation documentation and planning coming validation activities.

Main responsibilities

  • You will be the primary contact person to the chamber team.
  • You will be responsible for coordinating and plan project activities and yearly re-validations together the rest of the team.
  • Participate in projects as thermal validation subject matter expert.
  • Perform validation and re-validation protocols, reports, and the physical testing.
  • Data evaluate data and Deviation handling.
  • Coordinate with production, QC, warehouse, and engineering in relation to test.
  • Represent the area at regulatory and customer inspections.
  • Update procedures and instructions.
  • Responsible for our temperature loggers and their calibrated status.

Competences and skills

  • You hold a bachelor’s or another relevant technical education. Most important is that you have at least 2-3 years of relevant industry experience preferable within temperature mapping and/or validation.
  • You are self-starting and have a flexible, dynamic approach to work.
  • knowledge with validation, preferable validation of temperature-controlled rooms and equipment.
  • Used to write and review validation report/ protocols and perform validation testing.
  • Good English skills spoken and written. English is the company language.
  • Experience from pharmaceutical production will be preferred.

You bring a friendly, can-do mindset, professionalism, and a good sense of humor.

Your application

Has this sparked your interest? Then we urge you to please upload your CV and cover letter in English as soon as possible as we screen candidates on a continuous basis:

https://fujifilmdiosynth.wd3.myworkdayjobs.com/en-US/External/details/Validation-Engineer---Chamber-validation_JR1262

The job will be removed when the right candidate has been identified.

In case you have any questions or doubts, then please do not hesitate to reach out to Hanne Toft, Sr. Manager Validation at +45 23712992.

 

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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Validation Engineer - Thermal validation, Hillerød, Denmark

Do you want to join an advanced biotech company that develops and manufactures some of the leading biological products on the market today and for the future? Then join FUJIFILM Diosynth Biotechnologies in Hillerød (FDBD), a biotech company that aspires to be the leading CDMO within our areas of expertise. 

We are looking for the right Validation Engineer or a candidate with experience as Validation Technician to the Chamber Validation team.

About the Department

The Chamber validation team is a part of the larger Validation department, responsible for equipment qualification and cleaning validation. The department is supporting the existing production facility but is also involved in the large expansion project where we are doubling the production capacity. The department will over the coming year grow in tact with the finalizing the new part of the factory.

About the Team you join and your Role 

The Chamber validation team consists of 3-4 people. The chamber validation team is responsible for validating and re-validation of freezers, refrigerators, incubators, and controlled rooms. You will be in contact with many different departments, such as QA, QC laboratories, Engineering, production, and warehouse in the Hillerød Facility. Your daily work will be a combination of setting up probes for temperature logging, data evaluation, preparing validation documentation and planning coming validation activities.

Main responsibilities

  • You will be the primary contact person to the chamber team.
  • You will be responsible for coordinating and plan project activities and yearly re-validations together the rest of the team.
  • Participate in projects as thermal validation subject matter expert.
  • Perform validation and re-validation protocols, reports, and the physical testing.
  • Data evaluate data and Deviation handling.
  • Coordinate with production, QC, warehouse, and engineering in relation to test.
  • Represent the area at regulatory and customer inspections.
  • Update procedures and instructions.
  • Responsible for our temperature loggers and their calibrated status.

Competences and skills

  • You hold a bachelor’s or another relevant technical education. Most important is that you have at least 2-3 years of relevant industry experience preferable within temperature mapping and/or validation.
  • You are self-starting and have a flexible, dynamic approach to work.
  • knowledge with validation, preferable validation of temperature-controlled rooms and equipment.
  • Used to write and review validation report/ protocols and perform validation testing.
  • Good English skills spoken and written. English is the company language.
  • Experience from pharmaceutical production will be preferred.

You bring a friendly, can-do mindset, professionalism, and a good sense of humor.

Your application

Has this sparked your interest? Then we urge you to please upload your CV and cover letter in English as soon as possible as we screen candidates on a continuous basis:

https://fujifilmdiosynth.wd3.myworkdayjobs.com/en-US/External/details/Validation-Engineer---Chamber-validation_JR1262

The job will be removed when the right candidate has been identified.

In case you have any questions or doubts, then please do not hesitate to reach out to Hanne Toft, Sr. Manager Validation at +45 23712992.

 

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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