Validation Engineer III - OSD/Packaging/AVI

Validation Engineer III role supporting pharmaceutical manufacturing at Thermo Fisher Scientific's Greenville facility. Position focuses on oral solid dose and packaging process validation, combining desk-based protocol development with hands-on manufacturing floor execution to ensure regulatory compliance and product quality.

Responsibilities

• Lead manufacturing process validation activities for oral solid dose pharmaceutical products
• Develop, execute, and document validation protocols including IQ, OQ, and PQ phases
• Perform packaging process validation and collect samples and process data on manufacturing floor
• Analyze validation data and prepare technical reports supporting regulatory compliance
• Collaborate with Manufacturing, Engineering, Quality, and Technical Operations teams on validation projects

Requirements

• Bachelor's degree in Engineering, Life Sciences, Chemistry, or related technical field
• 5+ years validation experience in regulated manufacturing, or advanced degree with 3+ years experience
• Proficiency developing and executing IQ/OQ/PQ validation protocols in GMP environments
• Strong knowledge of FDA cGMP regulations and pharmaceutical manufacturing practices
• Technical writing and documentation skills for validation protocols and reports
• Experience with manufacturing process validation, equipment qualification, and cleaning processes