Thermo Fisher Scientific · 4 hours ago
Staff QA Engineer
Greenville, NC
Full-time
Onsite
Senior Level, Lead/Staff
5+ years expThermo Fisher Scientific is a leader in scientific research and development, and they are seeking a Staff QA Engineer to lead the quality oversight of validation activities. This role involves mentoring junior engineers, coordinating validation processes across multiple sites, and ensuring compliance with regulations.
BioinformaticsBiotechnologyCloud Data ServicesConsultingHealth CareLife ScienceManagement Information SystemsOffice SuppliesPrecision Medicine
Responsibilities
Lead QA validation activities related to Facilities, Utilities, Engineering, Quality Control, and Operational equipment
Provide strategic quality oversight of facility and equipment commissioning and other activities
Review and approve: Equipment Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ) protocols and reports
Validation related deviations and discrepancies
Process Validation (PV), Cleaning Validation, and Computer System related protocols and reports
Lead QA support for risk assessment, FMEA, and change controls governing validation related activity
Coordinate and lead validation activities with multi-functional team members to ensure efficiency and compliance with regulations
Develop and maintain a safety and quality culture
Mentor and train junior QAV Engineers
Drive continuous improvement initiatives in validation processes
Qualification
Required
BS/BA in a scientific or related field required, preferably in Biology/Chemistry or Engineering
5+ years of experience in Quality and/or Validation
7+ years of cGMP experience in the pharmaceutical industry, Steriles manufacturing experience strongly preferred
Proven ability to lead and mentor multi-functional teams
Strong leadership skills and ability to work within a matrix organization
Ability to support and lead multi-functional and multi-site initiatives involving integration
Excellent written and oral communication skills; ability to communicate effectively with Senior Leadership and all levels below
Ability to prioritize, align and simplify, demonstrate enthusiasm, take accountability and drive for results
In-depth knowledge of cGMPs, technical writing, data management collection, and analysis
Exceptional interpersonal skills, including teamwork, facilitation, and negotiation
Ability to work independently, with a pro-active mentality to mitigate risk
Preferred
Advanced degree preferred
Steriles manufacturing experience strongly preferred
Benefits
Competitive salary
Annual incentive bonus plan
401K with company match up to 6%
Tuition reimbursement
A range of other employee benefits
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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