Equipment Validation Engineer

Job Title: Equipment Validation Engineer

Location: Vacaville, CA - 95688

Duration: 12 Months

Job Type: Temporary Assignment

Work Type: Onsite

Shift:Monday to Friday from 08:00 AM to 05:00 PM

Pay rate: $30.00 - $35.00/hr.

Overview:

TekWissen is a global workforce management provider headquartered in Ann Arbor, Michigan that offers strategic talent solutions to our clients world-wide. Our client is a leading biotechnology company that combines technological insight with world-class manufacturing, scientific expertise, and process excellence and helps their customers to deliver new and innovative medicines that help treat a wide range of diseases. Our client specializes in pharmaceutical ingredients, Bioscience, Biopharmaceuticals, Custom manufacturing, Biotechnology, Life science ingredients, Nutrition, Microbial Control, Agriculture, Materials Science, Personal Care, and cell and gene therapy.

Summary

The Validation Engineer / Equipment Validation Engineer supports and executes QC laboratory equipment qualification activities under direct supervision. Ensure full compliance with current cGMP regulations and Roche/Genentech quality standards, policies, and core values. Maintain operational readiness, product supply continuity, and cost-effectiveness through participation in continuous improvement initiatives.

Responsibilities

• Perform laboratory equipment qualification activities according to established equipment qualification (EQ) policies, plans, and procedures.
• Collaborate with laboratory personnel to define equipment qualification requirements.
• Author, review, and execute equipment qualification protocols.
• Coordinate qualification activities with equipment vendors and internal support groups.
• Identify business, quality, and compliance gaps and support corrective actions.
• Review and sign qualification-related documents as authorized by company policies and procedures.
• Support QC laboratory operations through additional assignments as requested by senior management.
• Participate in continuous improvement projects to enhance laboratory efficiency and compliance.

Required Skills

• Bachelor's degree (BS/BA), preferably in a scientific discipline.
• Experience in the pharmaceutical, biopharmaceutical, or related regulated industry.
• Minimum 2 years of experience in equipment qualification and/or validation (preferred).
• Knowledge of cGMP regulations or equivalent regulatory requirements.
• Equipment qualification and validation execution.
• Protocol authoring, review, and execution.
• Regulatory compliance and cGMP knowledge.
• Gap assessment and compliance monitoring.
• Coordination with vendors and cross-functional teams.
• Strong verbal and written communication skills.
• Ability to influence stakeholders across different organizational levels.
• Relationship-building and collaboration skills.
• Strategic thinking with the ability to translate plans into actions.
• Strong organizational and prioritization skills.
• Sound decision-making and problem-solving abilities.
• Flexibility to adapt to changing priorities and business needs.
• Results-oriented mindset with accountability for outcomes.

TekWissen® Group is an equal opportunity employer supporting workforce diversity.