Validation Engineer II
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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