Validation Engineer II

SGS_JOB_2312

Scientific
 California
Validation
GMP
Equipment

Contract - 6 Months

Location - Vacaville California 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

Job 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.
  • 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
  • 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.
  • 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
  • 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.

Skills:

  • laboratory
  • cGMP
  • laboratory
  • QC
  • Validation
  • equipment qualification
  • cGMP
  • QC
  • Validation
  • equipment qualification

Education/Experience:

  • Bachelor's.
  • Bachelor's.

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