Process Validation Manager, Jobs, 7428

Engineering, Manufacturing & Supply Chain Recruitment

Process Validation Manager - Stirling & Falkirk

Engineering & Manufacturing - Engineering & Manufacturing
Ref: 7428 Date Posted: Friday 19 Feb 2021
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 Our client who are leader in revolutionary diagnostic led care solutions are going through a huge expansion in the manufacture of their life saving medical devices. They are looking for a Process Validation Manager to join their facility based in Alloa or Eurocentral.

What's in it for you?

  • Eurocentral or Alloa based (travel may be required between sites)
  • Excellent salary 
  • Opportunity to work with a dynamic and innovative company 
  • Permanent opportunity 
  • Career Progression

As a Process Validation Manager you will manage the development and execution of equipment and process validation.

You will responsible for delivery of validation and will travel between sites, both nationally and internationally.

Responsibilities:                

  • Oversight and deliver of equipment & process validation of all strip/assay designs across sites:
    • Validation Master plan
    • Facilities validation (IQ / OQ /PQ).
    • Equipment validation (IQ / OQ /PQ).
    • Re-validation (equipment / process changes).
    • Supplier validation (proposed process / product changes).
    • NPI (validation of new assays across sites)

 

  • Support & mentor the Engineering Team ensuring delivery of validation activities. 
  • Keep track of validation status across all products and equipment sets. 
  • Act as single point contact within all engineering teams for validation status and progress.
  • Oversee and develop validation approaches and strategy.
  • Development of test methods used to verify product and process performance
  • Working with Production, Process and Equipment Engineering Managers to schedule and execute the validation activities.
  • Liaising with external suppliers and collaborators to ensure methods and materials standards are up to current industry standards.
  • Ensuring GxP standards are maintained at all times in the team, and all documentation from the team is completed in a timely manner

Skills required:

  • Proven track record of timely and accurately development and execution of validation protocols.
  • Demonstrated FMEA, URS, FAT, SAT, VP, protocols, VSR etc experience.
  • Technical and team leadership skills - ability to lead by example and develop the skills and competency of the project team.
  • Project planning and coordination skills.
  • Detailed knowledge and understanding of how to handle materials and processes used within a test verification and validation environment. Test method development and validation.
  • Experience of working to ISO 13485 or FDA 21CFR, part 820 (or similar)
  • Experience of leading and managing technical teams. 

Please apply directly or contact Caroline Strachan on cstrachan@weareninetwenty.com