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Commissioning Qualification Validation Project Manager

DPS Group is looking for a Commissioning Qualification Validation Project Manager to work with a BioPharma client of ours in the Minneapolis area. Ideally, you are a natural leader, highly motivated and love the challenge of being a client representative on a pilot scale clean room facility and small-scale drug substance facility.

Category:
Engineer Process / Food / Dairy Science
Location:
Minnesota
Years of Experience Req.:
10+
Date Posted:
01/07/2019
Days Remaining:
48
Employment Type:
Full-time
Education Level Req.:
Bachelors

Your Responsibilities:

  • Represent the client managing the CQV program and overseeing a third-party commissioning and qualification company 
  • Write and execute validation protocols for new and existing equipment, facility utilities, and manufacturing processes.
  • Start-up C&Q experience of process and utility systems.
  • Role will involve authoring and executing CQV documentation for a defined system against project schedule and timelines.
  • Deviation/Nonconformance write up and close out resolution.
  • Provide direction, input, review and approval of engineering studies, FAT, IQ, OQ, and PQ validation protocols and reports for facilities, equipment, systems and utilities to ensure thoroughness, accuracy and compliance with company policies.

 

You have the following qualifications:

  • Bachelor’s degree 
  • 10+ years professional experience in a pharmaceutical environment
  • Experience developing and executing process, equipment, and cleaning validation protocols
  • Excellent written and verbal communication and interpersonal skills; prefer an individual with a positive, results oriented, team mindset and capable of changing direction and focus as priorities shift
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