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.