Sr. Validation Engineer - Wilson - Tekwissen

    Tekwissen
    Tekwissen Wilson

    2 days ago

    Description
    Overview:

    TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Our client is an American multinational information technology services and consulting company and is a leading provider of information technology, consulting, and business process outsourcing services, dedicated helping the world's leading companies build stronger businesses.

    Job Title: Sr. Validation Engineer

    Work Location: Wilson, NC, 27893

    Duration: 12+ Months

    Job Type: Temporary Assignment

    Work Type: Onsite

    Job Description:
    • The Senior Validation Engineer will lead and execute commissioning and qualification (C&Q) activities for automation systems at the.
    • This role ensures compliance with GMP regulations and internal quality standards, supporting the successful delivery of validation documentation and execution for new and existing systems.
    Key Responsibilities:
    • Lead and manage C&Q lifecycle activities including URS, DQ, IQ, OQ, and PQ for automation and process systems.
    • Collaborate with cross-functional teams including engineering, QA, manufacturing, and automation to ensure validation deliverables align with project timelines.
    • Develop and review validation protocols, reports, and supporting documentation in compliance with FDA, EU standards.
    • Utilize tools such as Kneat, GVault, or equivalent systems for document control and validation tracking.
    • Provide technical guidance and mentorship to junior validation engineers and contractors.
    • Support change control processes and deviation investigations related to validated systems.
    • Participate in audits and inspections, providing subject matter expertise on validation practices and documentation.
    • Ensure alignment with the overall execution and resource plan as outlined in the C&Q strategy.
    Required Qualifications:
    • Bachelor's or Master's degree in Engineering, Life Sciences, or related field.
    • Minimum 7+ years of experience in validation within the pharmaceutical or biotech industry.
    • Strong knowledge of cGMP, FDA, ICH, and EU regulations.
    • Proven experience with commissioning and qualification of automation systems.
    • Proficiency in validation tools such as Kneat, GVault, or similar platforms.
    • Excellent communication, documentation, and project coordination skills.
    Preferred Qualifications:
    • Experience working on large-scale C&Q projects in a regulated environment.
    • Familiarity with systems and validation practices is a plus.
    • PMP or equivalent project management certification.
    Top 3 must have's:
    • Life science Domain, Validation Skills, Delta V & MES Validation
    TekWissen Group is an equal opportunity employer supporting workforce diversity.

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