Not For C2C Candidates Please do not apply even not enquire
Job Title: CQV 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