Lead CQV Engineer/Analyst
Katalyst Healthcares & Life Sciences
- South Plainfield, NJ
- Permanent
- Full-time
· 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, PQRequirement
· Must be willing to work onsite in Syracuse, NY
· Bachelor's Degree or equivalent required
· 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
· 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
· 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
· Proven attention to detail and organization in project work
· Capable of working on assigned tasks without mentorship