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Validation Engineer
2 months ago
Not For C2C Candidates Please do not apply even not enquire
Job Title: Validation Engineer
Location: Countrywide USA
Contract Duration: 12+ months
Pay: Negotiable on w2 without any benefits
Responsibilities:
- 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
Requirement:
- 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
