Project Manager--CQV

Business NeedsRaleigh, NC
Onsite

About The Position

We are seeking a Project Manager with expertise in CQV (Commissioning, Qualification, and Validation) for the Life Sciences industry. This role is based in the Raleigh-Durham, North Carolina area. The ideal candidate will have 5-10+ years of experience in CQV or validation project management, with a strong understanding of GMP manufacturing environments. You will be responsible for leading cross-functional teams and overseeing on-site execution, including hands-on experience with IQ, OQ, PQ execution. Experience with various pharma/biotech manufacturing systems, facility systems, and exposure to automation, MES, or computerized system validation (CSV) is highly valued. This position is ideal for individuals with experience in startup, commissioning, or large capital projects.

Requirements

  • 5-10+ years of experience in CQV or validation project management
  • Strong knowledge of GMP manufacturing environments
  • Hands-on experience with IQ, OQ, PQ execution
  • Experience with pharma/biotech manufacturing systems (Process equipment, Utilities, Facility systems)
  • Ability to lead cross-functional teams and on-site execution
  • Experience in startup, commissioning, or large capital projects
  • Exposure to automation, MES, or computerized system validation (CSV)

Responsibilities

  • Manage CQV or validation projects.
  • Oversee on-site execution.
  • Lead cross-functional teams.
  • Execute IQ, OQ, PQ.
  • Manage projects related to pharma/biotech manufacturing systems, utilities, and facility systems.
  • Contribute to startup, commissioning, or large capital projects.
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