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Validation Engineer

2 months ago

Boston, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • Support CQV requirements, validation planning, protocol generation, test execution, configuration documentation, and system release.
  • Perform validation projects in a fast paced, facility startup schedule.
  • Manage cross-functional relationships with site stakeholders and vendors.
Requirements:
  • 5+ years of experience in a GMP pharma/biotech manufacturing facility authoring, reviewing and executing validation protocols for sterile injectable equipment lines
  • Related bachelors degree or higher (Engineering preferred)
  • Related LEAN and/or Six Sigma certificates and training