Description:
We are seeking a highly experienced Lead CQV-CSV Engineer to manage multiple client projects and provide technical leadership in commissioning, qualification, and validation (CQV), as well as computer system validation (CSV). This role requires strong client-facing capabilities, hands-on expertise, and the ability to work independently across GMP-regulated environments. The ideal candidate should possess comprehensive knowledge of validation planning, risk assessment, and technical execution for automated systems and GMP equipment.
Key Responsibilities:
- Manage and oversee multiple concurrent client projects, ensuring seamless execution.
- Act as the primary client-facing lead, managing project communication and acting as the escalation point for any project-related issues.
- Develop and design comprehensive validation plans and engineering studies.
- Review and verify system drawings, electrical schematics, and technical documentation.
- Perform and document impact assessments and risk assessments.
- Coordinate directly with equipment OEMs and installation vendors.
- Maintain thorough and audit-ready documentation for all qualification, validation, and change control processes.
- Author, review, and execute technical commissioning, qualification, and validation documents (URS, FAT, SAT, IQ, OQ, PQ).
- Execute test scripts and document outcomes with precision.
- Ensure adherence to project schedules and deliverables.
- Conduct hands-on user interface testing, software verification, and alarm testing for automated systems.
- Recommend design and process modifications based on test results and findings.
- Apply deep understanding of capital equipment implementation, process knowledge, and GMP regulations.
- Apply strong understanding of validation documentation, including User Requirement Specifications (URS), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
Required Skills & Qualifications:
- Minimum 10 years of experience in CQV/CSV roles within GMP-regulated industries.
- Proven experience in Commissioning & Validation activities, especially URS development for GMP equipment.
- Demonstrated ability to author and execute FAT, SAT, IOQ, and CSV protocols.
- Exceptional attention to detail and ability to work independently under minimal supervision.
- Formal training in GMP and Good Documentation Practices (training can also be provided during onboarding).
- Intermediate proficiency in Microsoft Word, especially for authoring and editing large technical documents with styles, tables, TOCs, and tracked changes.