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Validation Engineer II - Vacaville, CA

Validation Engineer II - Vacaville, CA

Unicon Pharma IncVacaville, CA, United States
30+ days ago
Job type
  • Full-time
  • Quick Apply
Job description

Description :

Shift Timings : M-F 8am - 4pm 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
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    Validation Engineer • Vacaville, CA, United States