CSV/CQV Engineer Responsibilities:
Looking for a strong resource with a diverse skillset focused around Data Integrity accompanied by a thorough understanding of both CSV and CQV principles.
- Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard manufacturing equipment/systems/ software, and processes as part of team as directed by the project leader
- Running test scripts and documenting results
- Adherence with project schedule for all assigned activities
- Maintaining clear, detailed qualification and validation records
- Basic understanding of system design and/or configuration activities
- General understanding of capital equipment implementation and process knowledge.
- Understanding validation documents, URS, IQ, OQ, PQ
- Understanding of system integrations, including but not limited to understanding of how integrations are designed / constructed, data flow from source systems to target systems, typical testing approach for system integrations
- Designing and executing engineering studies for critical process parameter definition and verification prior to validation
- Conducting and documenting impact and risk assessments with a full understanding of equipment/system/ software operation and ability to assess direct, indirect, and no impact systems and functions within complex processes
Requirements
- Bachelor's Degree or equivalent required
- Proficiency using PC and Microsoft Office tools
- Ability to work as part of a team
- Strong problem-solving and critical thinking skills
- Excellent organizational and time management skills
- Strong attention to detail
- Obvious business maturity and interpersonal skills to be able to effectively communicate and collaborate
- Experience and capability of effectively communicating requirements (written and orally) with rationale to different levels of the client's organization
- Experience in pharmaceutical cGxP setting with the ability to generate CSV/CQV deliverables
- Ability to work as part of a team
- Direct experience and understanding of complex automated lab and manufacturing systems
