CQV Engineer - Katalyst Healthcares & Life Sciences
Muskegon, MI 49440
About the Job
Responsibilities:
- CQV Engineer needed to perform qualification document generation (FAT, SAT, etc.) and execution for equipment such as tanks, CIP skids and utilities.
- Authoring, editing, and executing technical commissioning, qualification and validation documentation for standard 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 records qualification and validation.
- Documenting impact and risk assessments as part of a team.
- Completing user interface testing, software verification, and complete alarm testing on automated systems.
- Developing, reviewing, and executing testing documentation.
- Making recommendations for design or process modification based on test results when executing test scripts.
- General understanding of capital equipment implementation and process knowledge.
- Understanding validation documents, URS, IQ, OQ, PQ.
- Demonstrated experience in leading CQV activities specific to expertise in Facility and Utility qualification. Including qualification of Cleanrooms (including EMPQ), Warehouse, Compressed Gases, WFI, etc.
- Proficiency using PC and Microsoft Office tools.
- Outgoing personality with strong ability to communicate effectively with peers in clear, concise terms.
- GMP and Good Documentation Practice.
- Intermediate skills with WORD (authoring/editing large technical documents with styles, tables, TOCs, track changes).
- Basic skills with EXCEL and PowerPoint.
- Strong interpersonal skills and clear communication capabilities.
- Experience with and tolerance for high levels of challenge and change.
- Experience in GMP regulated environment.
- Capable of working on assigned tasks without mentorship.
Source : Katalyst Healthcares & Life Sciences
