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Equipment Validation Engineer

2 months ago

Raleigh, United States Insight Global Full time

Qualifications:

  • Bachelor's degree in Engineering or related field
  • 3+ years of validation experience in a cGMP environment, supporting equipment qualification and facilities commissioning activities
  • Knowledge of validation software systems: Kneat

Pluses:

  • Master's Degree Engineering or related field

Responsibilities:

A pharmaceutical company in the Raleigh, NC area is looking for an Equipment Validation Engineer to join their growing team. This person will be responsible for:

  • Providing support for autoclaves, isolators, parts washers, decontamination area, etc
  • Generates operational protocol(s), qualification IQ, OQ, PQ protocols and SOPs for various equipment/systems/processes in the facility
  • Author/review executed equipment qualification protocols and summary report
  • Drive planning activities
  • Assist with the execution of equipment qualification protocols
  • Provide hands on support to the manufacturing areas as required to assist in problem solving and long-term changes that provide product/process improvements in relation to equipment failures; Collect and analyze data to make data driven recommendations/decisions
  • Production oversight during validation events
  • Provide qualification support for systems as assigned.
  • Work on other projects and tasks as needed to support the site.