• Validation Engineer II

    ThermoFisher Scientific (Santa Clara, CA)


    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, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

    Job Description

    As a Validation Engineer II, you will support validation and qualification activities for TruBio software and bioprocessing equipment. You will write and execute validation protocols, partner with engineers across teams, and help deliver accurate, audit-ready documentation for customers.

     

    What will you do?

     

    + Support validation projects from planning through execution.

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

    + Identify and resolve issues during testing with guidance from senior engineers.

    + Participate in customer-facing FAT activities and support documentation reviews.

    + Partner with Field Service during qualification and commissioning.

    + Help with risk assessments, traceability, and deviation investigations.

    + Improve validation templates and contribute to process updates.

    Education

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

    Experience

    + 2 years of validation experience in biotech, pharma, or regulated manufacturing (limited experience acceptable with advanced degree)

    + Experience with FAT/SAT/IQ/OQ execution.

    + Exposure to customer interactions during testing or FAT is a plus.

    + Familiarity with Computer System Validation (CSV) concepts.

    + Experience with automation systems such as DeltaV, PLC/SCADA, or similar is preferred.

    Skills

    + Understanding of GAMP, cGMP, GDP, and **21 CFR Part 11 compliance** .

    + Strong attention to detail and documentation accuracy.

    + Good technical writing and communication skills.

    + Proficient in Microsoft Office; VBA or scripting experience is helpful.

    + Organized, willing to learn, and adaptable in a fast-paced environment.

    Physical Requirements and Work Environment:

    + On‑site role

    + Office setting

    What We Offer:

    + Annual performance-based bonus

    + Annual merit performance-based increase

    Excellent Benefits:

    + Benefits & Total Rewards | Thermo Fisher Scientific

    + Medical, Dental, & Vision benefits - Effective Day 1!

    + Paid Time Off & Designated Paid Holidays

    + Retirement Savings Plan

    + Tuition Reimbursement

    + Employee Referral Bonus

    + Career Advancement Opportunities

     

    Apply today! http://jobs.thermofisher.com

     

    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.

     

    Compensation and Benefits

     

    The salary range estimated for this position based in California is $72,000.00–$108,000.00.

     

    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.