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Syracuse

    Senior Quality Engineer - Syracuse, United States - Premier Life Sciences LLC

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    Description
    Senior CQV Engineer
    Syracuse, NY, United States
    Contract

    Senior CQV Engineer 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


    • Must be willing to work onsite in Syracuse, NY
    • Bachelor's Degree or equivalent required
    • Demonstrated experience in leading CQV activities specific to facility, utility, and process equipment including autoclaves and fillers
    • 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.
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