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Sr. Validation Engineer

2 months ago

Raleigh, United States Technical Source Full time
Job DescriptionJob Description

Technical Source is currently in search of a Sr. Validation Engineer for our pharmaceutical manufacturing client in the Western NC area. The qualified candidate will have experience writing and executing validation protocols for PLC based automated control systems as well as automated manufacturing equipment in a pharmaceutical manufacturing environment.

Responsibilities of the Sr. Validation Engineer include:

  • Execution of validation protocols (IQ/OQ) for PLC based controls systems
  • Authors cGMP risk assessments, user requirements & functional specifications, validation plans, protocols (i.e. IQ, OQ, PQ), traceability matrices, reports, addendums, decommissioning plans and other validation deliverables as required by the site validation SOPs.
  • Complete appropriate cGMP documentation throughout validation life cycle

Qualifications of the Sr. Validation Engineer include:

  • 5+ years of experience in the qualification of automated manufacturing and lab equipment
  • Experience with cGMP documentation review and execution
  • Bachelor's or Associates degree in related field preferred

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