Validation Engineer I

HireTalent

  • Vacaville, CA
  • 30+ days ago

    Highlights

    Maintains company s right to operate, supply to patients, and cost effectiveness by actively participating in continuous improvement projects. Knowledge/Skills/Competencies: Possesses strong verbal and written communication skills and the ability to influence at all levels.

    Numbers & Facts

    LocationVacaville, CA

    Description

    Job Title: Validation Engineer I
    Location: Vacaville, CA
    Duration: 06 Months


    Shift: M-F 8am - 4pm (including unpaid lunch 30 mins) 5x onsite

    Job Summary:
    • With direct supervision, candidate is responsible for support and execution of QC laboratory equipment qualification activities while in full compliance with current cGMP regulations and Roche/Genentech corporate principals, quality policies, standards and core values.
    • Maintains company s right to operate, supply to patients, and cost effectiveness by actively participating in continuous improvement projects.
    Duties:
    Technical:
    • Perform qualification of laboratory equipment in accordance with EQ policies, plans and procedures.
    • Coordinate with laboratory personnel to define qualification requirements.
    • Author, review and execute equipment qualification protocols.
    • Coordinate equipment qualification activities with vendors and other support groups.
    • Identify business, quality, and compliance gaps.
    • Sign documents for activities as authorized and described by Genentech policies, procedures and job descriptions.
    • Perform any other tasks as requested by Senior Management to support QC laboratory operations.
    Job Requirements:
    Education:
    • BS/BA degree (preferably in relevant scientific discipline)
    • Experience (may vary depending on site size/scope)
    • Experience in the pharmaceutical, biopharmaceutical industry or an equivalent combination of education and experience.
    • Knowledge of cGMP or equivalent regulations.
    • Minimum of two years experience in Validation or equipment qualification is desired.
    • Ability to make sound decisions about scheduling and managing of priorities.
    • Flexibility in problem solving, providing direction and work hours to meet business objectives.
    Knowledge/Skills/Competencies:
    • Possesses strong verbal and written communication skills and the ability to influence at all levels
    • Capable of building trustful and effective relationships
    • Able to think strategically and translate strategies into actionable plans
    • Takes responsibility, drives results, and achieves expected outcomes
    Work Environment/Physical Demands/Safety Considerations:
    • Standard office environment

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