Staff Validation Engineer
Greenville, NCJobSeen 2 days agoSeen in employer's feed 2 days ago
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At a glance
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Job overview
The Staff Validation Engineer leads validation activities for systems, equipment, and processes supporting therapy development and manufacturing. In a GMP environment, the role develops and implements validation strategies aligned with regulatory requirements and corporate standards, and collaborates across teams on qualification and lifecycle activities. The engineer supports compliance, continuous improvement, audits, and investigations, serves as a technical subject matter expert, and may mentor team members.
Skills & qualifications
Skills
Qualifications
Full job description
Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job Description
As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
DESCRIPTION:
Join our validation team at Thermo Fisher Scientific, where you'll contribute to global healthcare and scientific advancement. As a Staff Validation Engineer, you'll lead validation activities for critical systems, equipment, and processes that enable the development and manufacturing of therapies.
Working in a GMP environment, you'll develop and implement comprehensive validation strategies aligned with regulatory requirements and corporate standards. You'll collaborate with cross-functional teams to ensure the successful qualification of facilities, utilities, manufacturing equipment, and computerized systems throughout their lifecycle.
Your expertise will be vital in maintaining compliance, driving continuous improvement, and serving as a technical subject matter expert during audits and investigations. You'll have opportunities to mentor team members while working on diverse projects ranging from new product introductions to complex system validations.
REQUIREMENTS:
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Advanced Degree plus 6 years of experience, or Bachelor's Degree plus 8 years of experience in validation experience in pharmaceutical/biotech manufacturing or related GMP environment
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Preferred Fields of Study: Engineering, Science, Biotechnology, or related technical field
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Expert knowledge of cGMP regulations, GAMP 5, 21 CFR Part 11, and international regulatory requirements
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Strong experience with validation lifecycle documentation including risk assessments, validation plans, IQ/OQ/PQ protocols, and summary reports
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Demonstrated expertise in computerized system validation and data integrity requirements
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Experience with manufacturing equipment, utilities, and facility qualification
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Proven project management skills and ability to lead multiple concurrent validation projects
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Strong analytical and problem-solving capabilities
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Excellence in technical writing and documentation
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Strong communication and interpersonal skills
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Ability to influence and coordinate activities across multiple departments
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Proficiency with validation tools and standard office software
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Experience mentoring validation staff
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Travel occasionally (<15%) as needed
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Physical ability to work in both office and manufacturing environments
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.
How this job compares
Set against the 476 open Validation Engineer jobs on Olive Jobs, counted November 3, 2026.
- Pay
- This postingNot listed
- US median$120–170K/yr245 salary ranges
- US median$50–59/hr36 hourly ranges
- Openings
- Olive Jobs lists 29 open Validation Engineer jobs in North Carolina and 476 across the US. 1% of them nationwide are listed as remote or flexible.
- Hiring the most in North Carolina
- Fujifilm7 open
- ThermoFisher Scientific (this employer)5 open
- Barry-Wehmiller3 open
- Experience
- This posting asks for at least 6 years of experience; Validation Engineer postings that state a minimum ask for 5 years at the median (359 postings).
- Education
- 271 of the 476 open Validation Engineer jobs (57%) ask for a bachelor's degree or higher.
Counted across the open, public US postings on Olive Jobs on November 3, 2026. Pay medians are the middle values of the low ends and of the high ends of postings that list both ends of a range in the same cadence (a yearly salary or an hourly rate); a range's midpoint is halfway between its ends. Pay and experience figures resting on fewer than 20 postings are left out.
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