Lead CQV-CSV Engineer

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