What are the responsibilities and job description for the CQV Project Lead – GMP Facilities, Utilities & Equipment position at QvalFocus Inc.?
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