CQV Project Lead - GMP Facilities, Utilities & Equipment Job at QvalFocus Inc., Boulder, CO

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  • QvalFocus Inc.
  • Boulder, CO

Job Description

We are looking for an experienced validation professional to support commissioning, qualification, and validation (CQV) activities across facility, utility, equipment, cleaning, and process systems in a GMP environment.

Responsibilities:

  • Act as our representative and interface with client stakeholders
  • Coordinate internal and external resources to support validation project execution
  • Support commissioning and validation activities across facilities, utilities, equipment, cleaning, and process systems
  • Prepare and execute validation lifecycle documentation including:
  • URS, SRS, FRS, DDS
  • Risk Assessments, Traceability Matrices (RTM)
  • FAT, SAT, IQ, OQ, PQ protocols
  • Final Validation Summary Reports
  • Develop validation plans, project schedules, and execution strategies
  • Perform system and process risk assessments and support technical decision-making
  • Support greenfield projects, facility upgrades, product launches, and process improvements
  • Write SOPs and technical procedures for validated systems
  • Coordinate protocol execution with manufacturing, facilities, and project teams.

Qualifications:

  • 8-10 years of GMP validation / CQV experience
  • Strong hands-on experience in protocol writing and execution
  • Exposure to facility, equipment, and process validation
  • Ability to lead small teams or workstreams while remaining technically involved
  • Good communication and stakeholder coordination skills

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