Validation Engineer

5 days ago

Fairfield, CA, United States Katalyst Healthcares and Life Sciences Full time
Responsibilities:
  • 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.
  • Perform qualification of laboratory equipment in accordance with EQ policies, plans and procedures.
  • Coordinate with laboratory personnel to define qualification requirements.
  • uthor, 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.
Requirements:
  • 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.
  • bility 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.
  • ble to think strategically and translate strategies into actionable plans.
  • Takes responsibility, drives results, and achieves expected outcomes.

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