Thermo Fisher Scientific · 9 hours ago
Engineer III, Validation
Greenville, North Carolina, USA
Full-time
Onsite
Senior Level
5+ years expThermo Fisher Scientific is a global leader in serving science, and they are seeking a Validation Engineer III to join their validation engineering team. This role involves leading complex validation projects to ensure product quality and regulatory compliance across pharmaceutical manufacturing operations, while contributing to continuous improvement initiatives and supporting cross-functional teams.
Research
Responsibilities
Ensure product quality and regulatory compliance across pharmaceutical manufacturing operations
Lead complex validation projects for equipment, processes, utilities, and computer systems
Collaborate with cross-functional teams to maintain GMP standards
Contribute to continuous improvement initiatives
Support team members
Provide technical expertise during client and regulatory audits
Qualification
Required
Bachelor's Degree in Engineering, Life Sciences, Chemistry or related technical field
5 years of experience in validation in pharmaceutical/biotech manufacturing or comparable regulated industry
3 years of experience in validation in pharmaceutical/biotech manufacturing or comparable regulated industry with an advanced degree
Experience writing and executing validation protocols, including IQ/OQ/PQ documentation
Expertise in risk assessment methodologies and statistical analysis
Experience leading complex validation projects and coordinating cross-functional teams
Advanced problem-solving abilities and root cause analysis experience
Strong knowledge of cGMP regulations, including FDA, EMA and ISO requirements
Proficiency with validation of manufacturing equipment, utilities, cleaning processes and computer systems
Strong technical writing and documentation skills
Excellent verbal/written communication and interpersonal skills
Proficiency with relevant software tools (MS Office, statistical packages, validation systems)
Knowledge of lean manufacturing and continuous improvement methodologies
Ability to work in cleanroom environments when required
Flexibility to work extended hours or alternate shifts based on project needs
Preferred
Advanced degree preferred
Experience with regulatory inspections and client audits preferred
Company
Thermo Fisher Scientific
The world leader in serving science To serve science, Thermo Fisher Scientific needs to stay ahead of it, we need to anticipate customer needs.
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
Late StageLeadership Team
Heather Stewart
HR Business Partner - Global Enterprise Services
Laura Green
Associate Human Resources Business Partner
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