Validation Engineer

We are looking for Validation Engineers to join our Information Technology Department. You will be part of setting the overall Computerised System Validation (CSV) strategy and set the direction on CSV for specific projects and implementations.

Fujifilm Diosynth Biotechnologies is a company on the journey to become the leading and most trusted global Contract Development and Manufacturing Organization partner in the biopharmaceutical industry. A great opportunity to accelerate your career and join a great company.

Information Technology is a part of Digital Technologies which is a fast growing department responsible for driving the digital transformation for the site. You will be surrounded by highly dedicated and skilled colleagues who all works on the mission of ensuring stable, efficient and compliant IT solutions. Simplicity and agility is important in everything we do.

You will be part of a newly established team Project Execution and CSV within the IT Department where we are looking for more colleagues to join. The team will consist of project managers, covering both IT and Automation projects, and validation engineers.

Tasks:

  • Support in setting the overall Computerised System Validation (CSV) strategy and set the direction on CSV for specific projects and implementations
  • Execute and coordinate validation tasks and support projects in Digital Technologies and support areas, to keep the equipment and systems in compliance
  • Identify and implement improvements in the Hillerod facility
  • Support the Computerised System Validation team to prepare and execute projects in compliance
  • Contribute with knowledge and experience in validation issues

Requirements:

  • Master’s Degree in engineering, computer science or similar.
  • 5-10 years industry relevant experience in related areas preferably within the pharmaceutical industry.
  • Experience with production; IT Projects, Documented ISO and cGMP understanding and knowledge to GAMP
  • In depth knowledge of regulatory requirements and expectations
  • Experience with areas beyond system validation
  • Quality minded
  • Structured with strong analytical skills
  • Strong networking and interpersonal skills
  • High sense of responsibility

Your Application

Please upload your CV and cover letter as soon as possible. If you need more information about the role, please contact Gitte Brynningsen at phone +45 41949994

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