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CQV Lead

The Hillerød Validation Engineering team seeks to recruit a Senior Validation Engineer. The Validation team is part of Engineering Support, with responsibility for maintaining the validated state of equipment within the Large-Scale Manufacturing drug substance facility. This includes qualification of new equipment, chamber validation, cleaning validation and participation in projects / changes.

About the position

The Senior Validation Engineer will be organized within the operations team with heavy involvement in the expansion project organization, to ensure alignment between the ongoing operations that support existing drug substance manufacturing and the expansion projects on site. Further, the person should anchor the learnings and experiences from the current project to improve the current CQV approach and prepare for future expansions. This position is a great opportunity to impact and improve the current way of working and set the direction on how FDB will approach qualification of large-scale drug substance manufacturing equipment for future expansions.

Main responsibilities

  • Be part of the FDB expansion projects, both on the planning and execution level
  • Coordinate, plan, perform and document commissioning, IQ, OQ and PQ activities
  • Support Project Manager and Work Package Owners during testing
  • Continuously compare operations and project approach, communicate best practises, ensure alignment
  • Communicate project status and progress to the operational organization
  • Participation in audits and inspections

The successful candidate will

  • Have experience from major pharmaceutical projects from direct participation in CQV work
  • Have at least 10 years of relevant industry experience
  • Be able to independently create qualification documentation for Design, FAT, SAT, Commissioning, IQ, OQ and PQ.  
  • Good knowledge of agency requirements for equipment qualification
  • Have excellent communication / presentation skills, and be able to articulate complex information to stakeholders and supporting functions such as QC, QA, Engineering, Automation and others
  • Be familiar with risk-based approach, preferable the ASTM E2500 standard for qualification
  • Have knowledge of multiproduct product line and facilities
  • Be a team player who works well with colleagues and cross-functional teams
  • Hold a Bachelors or higher degree in a relevant discipline
  • Be self-starting and have a flexible, dynamic approach to work
  • Bring a friendly, can-do demeanour, professionalism and a good sense of humour

 

Degrees of interest: Engineering