Lead CQV-CSV Engineer Responsibilities:
- Manage multiple projects and clients simultaneously.
- Lead client-facing activities and handle responsibilities.
- Serve as the escalation point for issues on client projects.
- Design validation plans and engineering studies.
- Verify system drawings and electrical schematics with support.
- Conduct and document impact and risk assessments.
- Work with equipment OEMs and installation vendors.
- Maintain detailed records of qualification, validation, and change control activities.
- Create and execute technical commissioning, qualification, and validation documents.
- Run test scripts and document results.
- Adhere to project schedules.
- Perform user interface testing, software verification, and alarm testing on automated systems.
- Develop, review, and execute testing documentation.
- Recommend design or process modifications based on test results.
- Understand capital equipment implementation and process knowledge.
- Understand validation documents like URS, IQ, OQ, and PQ.
Key Responsibilities:
- Minimum of 10 years of CQV/CSV experience in GMP regulated environments
- Must have experience in Commissioning & Validation activities covering URS (GMP equipment)
- Must have experience authoring and executing FAT, SAT, IOQ, CSV Protocols
- Proven attention to detail and capabilities of working independently
- GMP and Good Documentation Practice training (may be completed at on-boarding)
- Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes
