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Work Schedule

Standard Office Hours (40/wk)

Environmental Conditions

Able to lift 40 lbs. without assistance, Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

Job Description

As a Validation Engineer III, you will lead validation and qualification work for TruBio software and bioprocessing equipment. You will own key validation deliverables, guide junior engineers, and work with Engineering, Software, Quality, and Field Service to deliver reliable, audit-ready systems.

What will you do?

+ Lead validation projects from planning to closeout.

+ Write and execute FAT, SAT, IQ, and OQ protocols.

+ Resolve issues found during testing and document results.

+ Lead customer-facing FAT activities and support audits.

+ Partner with Field Service during Commissioning & Qualification.

+ Support risk assessments, traceability, and deviation investigations.

+ Improve validation templates and processes.

+ Mentor junior engineers and support digital validation tools.

Education

+ Bachelor’s degree in Engineering, Computer Science, Life Sciences, or related field; equivalent experience considered.

+ Advanced degrees or validation/quality certifications are a plus.

Experience

+ 5 years of validation experience in biotech, pharma, or regulated manufacturing (3 years with advanced degree or equivalent work experience).

+ Experience leading FAT/SAT/IQ/OQ activities.

+ Customer-facing experience during qualification or FAT.

+ Familiarity with CSV principles and tools like ValGenesis or Kneat.

+ **Hands-on experience** with DeltaV, PLC/SCADA, or similar systems.

+ Experience mentoring or supporting junior engineers.

Skills

+ Strong knowledge of GAMP, cGMP, GDP, and 21CFR Part 11 compliance.

+ Strong technical writing and communication skills.

+ Good problem-solving and documentation accuracy.

+ Proficient in Microsoft Office; VBA or scripting is a plus.

+ Organized, adaptable, and effective in a fast-paced environment.

Compensation and Benefits

The salary range estimated for this position based in California is $90,900.00–$136,350.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

+ A choice of national medical and dental plans, and a national vision plan, including health incentive programs

+ Employee assistance and family support programs, including commuter benefits and tuition reimbursement

+ At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

+ Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

+ Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.