Validation Engineer

Position Title: Validation Engineer

Work Location: Vacaville CA 95688

Assignment Duration: 6 Months

Work Schedule: M-F 8am - 4pm (including unpaid lunch 30 mins)

Work Arrangement: Onsite

Position 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 our organization's 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.

Key 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 our organization's policies, procedures and job descriptions.

• Perform any other tasks as requested by Senior Management to support QC laboratory operations.

Qualification & Experience:

• BS/BA degree (preferably in relevant scientific discipline)

• 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.

• 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

Working Conditions & Physical Demands (If Applicable): Standard office environment

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At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws.