QC Equipment Engineer - Vacaville, CA

Lenmar Consulting Inc; Vacaville (CA); On-site; USD 61,000 - 74,000; Full time

Job summary

Lenmar Consulting Inc. is seeking a QC Equipment Engineer in Vacaville, CA to support and execute QC laboratory equipment qualification activities in alignment with cGMP regulations and corporate policies.

You will collaborate with QC staff to define qualifications, author and review protocols, and coordinate with vendors to ensure compliant, timely equipment qualification. Strong communication and problem-solving skills are essential.

Qualifications

• BS/BA degree in a relevant scientific discipline.
• Experience in the pharmaceutical/biopharmaceutical industry or equivalent.
• Minimum of two years’ experience in validation or equipment qualification.
• Knowledge of cGMP or equivalent regulations.
• Strong verbal and written communication skills.

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.

Skills

Communication

Influence at all levels

Strategic thinking

Prioritization

Collaboration

Education

BS/BA degree

Job description

Title: QC Equipment Engineer

Location: Vacaville, CA 95688

Pay Range: $44/hr - $54/hr

Duration: 12 months contract with possible extension or full time conversion

Schedule: Monday - Friday, 8:00 AM - 4:00 PM (includes a 30-minute unpaid lunch)

Job Summary

With direct supervision, the candidate is responsible for the support and execution of QC laboratory equipment qualification activities while in full compliance with current cGMP regulations and corporate principles, quality policies, standards, and core values. Maintains the company’s right to operate, supply to patients, and cost-effectiveness by actively participating in continuous improvement projects.

Technical 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.

Education

BS/BA degree (preferably in a 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 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