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Validation Engineer

Company:
Premier Life Sciences LLC
Location:
New York, NY
Posted:
May 12, 2024
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Description:

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

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