Thermo Fisher Scientific · 13 hours ago
Staff Validation Engineer
Santa Clara, CA
Full-time
Onsite
Senior Level, Lead/Staff
$112K/yr - $188K/yr
7+ years expThermo Fisher Scientific is a leading company in the biotechnology and pharmaceuticals sector, and they are seeking a Staff Validation Engineer. The role involves leading validation strategies for software and bioprocessing systems, mentoring engineers, and ensuring compliance with regulatory standards.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
Responsibilities
Lead and define validation strategies for TruBio software and bioprocessing systems, aligning with cGMP, GAMP 5, and customer expectations
Serve as the technical lead for qualification and validation, providing direction to project teams across Integration, Field Service, Software, and Quality functions
Develop and approve key validation deliverables—including risk assessments, master plans, FAT/SAT/IQ/OQ protocols, and final summary reports—for both standard and custom systems
Champion collaboration with customers, leading Factory Acceptance Testing (FAT) and supporting audits with confidence and technical expertise
Drive innovation and continuous improvement, finding opportunities to simplify validation processes, automate documentation, and strengthen quality systems
Coach and mentor engineers, promoting a culture of learning, technical excellence, and proactive problem-solving
Lead investigations into deviations and complaints, ensuring timely and effective root cause analysis and corrective actions
Partner with leadership to establish guidelines and validation standards that support digital transformation initiatives like ValGenesis or Kneat
Contribute to organizational strategy by aligning validation processes with business goals and customer needs
Qualification
Required
Bachelor's degree (or equivalent experience) in Engineering, Computer Science, or related technical field
7+ years of validation experience within biotechnology, pharmaceuticals, or regulated manufacturing environments
Proven success leading sophisticated qualification projects from planning to closeout (FAT, SAT, IQ/OQ)
Proven track record to mentor, coach, and influence others across multiple teams
Hands-on experience with automation systems such as DeltaV, PLC/SCADA, or similar platforms
Experience implementing Computer System Validation (CSV) programs and using digital validation tools (ValGenesis, Kneat)
Track record of improving processes and standardizing validation documentation
Strong understanding of GAMP 5, cGMP, GDP, and 21 CFR Part 11 compliance frameworks
Strong understanding of New Product Introduction (NPI) process and product Life cycles
Excellent communication and technical writing skills, with a focus on clarity and collaboration
Ability to navigate complex problems and propose practical solutions
Skilled in Microsoft Office and familiar with scripting tools or VBA for data analysis and automation
Adaptable, collaborative, and energized by working in a dynamic and multi-functional environment
Preferred
A Master's degree is preferred
Advanced degree or professional certification in validation, automation, or quality preferred
Benefits
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
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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