Thermo Fisher Scientific · 9 hours ago
Validation Engineer II
Santa Clara, CA
Full-time
Onsite
Entry, Mid Level
$72K/yr - $108K/yr
2+ years expThermo Fisher Scientific is a leading company in the biotechnology sector, and they are seeking a Validation Engineer II to support validation and qualification activities for TruBio software and bioprocessing equipment. The role involves writing and executing validation protocols and collaborating with engineers to ensure accurate documentation for customers.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
Responsibilities
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
Qualification
Required
Bachelor's degree in Engineering, Computer Science, Life Sciences, or related field; equivalent experience considered
2 years of validation experience in biotech, pharma, or regulated manufacturing (limited experience acceptable with advanced degree)
Experience with FAT/SAT/IQ/OQ execution
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
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.)
Preferred
Experience with automation systems such as DeltaV, PLC/SCADA, or similar
Exposure to customer interactions during testing or FAT
Benefits
Annual performance-based bonus
Annual merit performance-based increase
Medical, Dental, & Vision benefits - Effective Day 1!
Paid Time Off & Designated Paid Holidays
Retirement Savings Plan
Tuition Reimbursement
Employee Referral Bonus
Career Advancement Opportunities
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
Company
Thermo Fisher Scientific
Thermo Fisher Scientific is a biotechnology and laboratory equipment company that provides a wide range of scientific products and services.
10001+ employees
H1B Sponsorship
Thermo Fisher Scientific has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (272)
2024 (224)
2023 (233)
2022 (342)
2021 (315)
2020 (227)
Funding
Current Stage
Public CompanyTotal Funding
$15.97BKey Investors
National Grid
2025-11-24Post Ipo Debt· $2.42B
2025-09-30Post Ipo Debt· $2.5B
2023-08-07Post Ipo Debt· $2.95B
Leadership Team
Stephen Williamson
Senior Vice President and Chief Financial Officer
Daniella Cramp
Senior Vice President and President, Bioproduction Group
Recent News
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2025-12-31
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2025-12-19
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