Thermo Fisher Scientific · 4 hours ago
Senior Deviation Management Engineer (REMOTE - East Coast)
United States
Full-time
Remote
Mid, Senior Level
$94K/yr - $141K/yr
3+ years expThermo Fisher Scientific is a global leader in serving science, and they are seeking a Senior Deviation Management Engineer to maintain compliance and operational excellence. This role involves leading investigations, performing root cause analysis, and collaborating across departments to improve product and process quality.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
Responsibilities
Support the tactical execution of the site Quality Management System (QMS) through deviation reduction, CAPA efficiency, and continuous improvement initiatives
Analyze deviation trends to identify systemic gaps, improvement opportunities, and training needs
Develop and monitor benchmarks aligned with site and corporate quality objectives
Lead and facilitate investigations for deviations, nonconformances, and quality events to resolve true root causes
Coordinate the Deviation Reduction Program and identify process improvements to minimize recurrence
Mentor and train Investigators in structured problem-solving methodologies and documentation guidelines
Ensure timely completion and closure of investigations and CAPAs in compliance with regulatory and internal standards
Collaborate with cross-functional teams to implement and verify the efficiency of corrective and preventive actions
Collaborate with complaint handling and pharmacovigilance teams to ensure accurate and timely adverse event reporting and safety communication
Provide technical expertise and investigation support for product-related complaints and safety events
Ensure alignment with internal procedures and external regulatory expectations (e.g., FDA, EMA, ISO)
Drive Right First-Time initiatives passionate about process development, standardization, and error-proofing
Employ root cause analysis and lean problem-solving techniques (e.g., 5-Why, Fishbone, DMAIC) to improve process robustness
Partner with Manufacturing, Engineering, and Quality functions to develop and implement standard work and process improvements
Traveling up to 50%, we visit suppliers to resolve manufacturing, quality, and technical issues, and prevent future problems
We provide supplier investigation ownership and apply enhanced problem-solving skills (six sigma) to identify true root cause, develop, and implement irreversible corrective actions. Provides efficient and effective solutions and CAPA management for supplier issues
Lead technical aspects for suppliers, optimizing materials and services
Responsible for communicating supplier issues to Leadership Team
We participate in periodic business and relationship review meetings with problematic suppliers
We serve as a primary point of contact to Thermo Fisher manufacturing sites and suppliers in the region. Influences internal partners and works across functional boundaries to identify business needs, establish standard processes, ensure alignment, and mitigate risk
Responsible for ensuring a data-driven Global Supplier Management program that focuses on identifying and mitigating risk across the direct material supply chain
Qualification
Required
Bachelor's degree in Engineering, Science, or Business is required
Extensive experience in regulated environments (GMP a plus) in Pharma, Med Device, OTC Drug, Cosmetics, Food, Automotive, or Aerospace
Proven experience of at least 3 years in each position within a minimum of 2 of the following areas: Operations, Quality, Procurement, and/or Supply Chain Management
Experience in data management, collection, analysis, technical writing, and driving continuous improvement with a track record of achieving result
Benefits
Annual incentive plan bonus scheme
Healthcare
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
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
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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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