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Validation Engineer

Validation Engineer

Katalyst HealthCares & Life SciencesSt. Louis, MO
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Responsibilities :

  • The Validation Engineer develops documentation for the Commissioning, Qualification, and Validation of pharmaceutical facilities, utilities, and equipment.
  • Our Engineers are responsible for protocol writing and execution (field verification), and development of summary reports.
  • Ability to multi-task and take initiative to accomplish assigned tasks accurately by established deadlines.
  • Ability to work independently.
  • Support onsite and offsite activities, such as : FATs, SATs, IOQ and PQ Executions and System Walkdowns.

Requirements :

  • BS or MS in a relevant science or engineering field, or equivalent years of hands-on experience.
  • years relevant experience commissioning / validating in an FDA regulated industry.
  • Autoclave / Parts Washer Qualification experience is required.
  • Experience in or more of the following is desired : facilities and equipment startup, walk downs & troubleshooting, utilities (WFI, RO, HVAC), building automation or other pharmaceutical manufacturing processes and equipment, FAT / SAT, URS, design review, P&IDs, IQ / OQ / PQs, generation & execution, etc.
  • Excellent technical problem-solving and troubleshooting skills.
  • High attention to detail.
  • Expertise in Microsoft Word and Excel
  • Excellent oral and written English are required.
  • Able to travel domestically and internationally if required.
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    Validation Engineer • St. Louis, MO