Validation Engineer I
Aequor JD ·www.aequor.com
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M-F 8am - 4pm (including unpaid lunch 30 mins) 5x onsite
Job 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.
Duties:
Technical:
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.
Job Requirements:
Education:
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.
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
Able to think strategically and translate strategies into actionable plans
Takes responsibility, drives results, and achieves expected outcomes
Work Environment/Physical Demands/Safety Considerations:
Standard office environment
Job 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.
Duties:
Technical:
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.
Job Requirements:
Education:
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.
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
Able to think strategically and translate strategies into actionable plans
Takes responsibility, drives results, and achieves expected outcomes
Work Environment/Physical Demands/Safety Considerations:
Standard office environment
Frequently asked questions
Who is hiring for the Validation Engineer I role?
Aequor JD is hiring for the Validation Engineer I position, a Shazamme client. Apply directly on the employer's career site.
Where is the Validation Engineer I job located?
The Validation Engineer I role with Aequor JD is based in Vacaville, CA, US.
What does the Validation Engineer I role pay?
Aequor JD lists the Validation Engineer I role at USD 26–44 per hour.
Is the Validation Engineer I role full-time or contract?
This is a full time position at Aequor JD.
What experience level is the Validation Engineer I role?
The Validation Engineer I position is aimed at mid-level candidates.
How do I apply for the Validation Engineer I role at Aequor JD?
Apply directly on Aequor JD's career page via the Apply button on this listing. ZammeJobs links straight through to the employer's ATS — no third-party form, no resume database.