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Validation Engineer
Validation EngineerKatalyst HealthCares & Life Sciences • Vacaville, CA
Validation Engineer

Validation Engineer

Katalyst HealthCares & Life Sciences • Vacaville, CA
[job_card.30_days_ago]
[job_preview.job_type]
  • [job_card.full_time]
[job_card.job_description]

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.

Roles & Responsibilities :

  • 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.
  • Perform any other tasks as requested by Senior Management to support QC laboratory operations.

    • Education & Experience :

  • 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.
  • 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
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