Engineer III, Validation

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, Cold Room/Freezers
-22degreesF/-6degrees C, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)

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.

Join our Validation Engineering team in Greenville, North Carolina, and help ensure reliable, compliant pharmaceutical manufacturing through commissioning, qualification and validation (CQV). In this role, you will support validation activities across the site for manufacturing equipment, facilities, utilities, storage, automation controls and related systems. You will work both independently and with cross-functional teams in an aseptic processing environment, applying sound engineering principles, risk-based thinking and procedural compliance to support safe, consistent operations.

This is an opportunity to broaden your technical experience across multiple areas of pharmaceutical manufacturing while contributing to site-wide process improvement. The team is highly collaborative, works hard, engages one another respectfully and operates as a unified group focused on improving site processes.

• Plan, author, review and execute commissioning, qualification and validation protocols and associated documentation for equipment, facilities, utilities, storage and manufacturing processes.
• Verify completion of validation activities associated with projects and quality-related work, ensuring documentation is accurate, complete and compliant with site procedures and cGMP expectations.
• Support qualification and verification of automation controls and computer-related systems associated with process equipment used in pharmaceutical manufacturing.
• Develop and apply risk assessments to determine validation strategy, testing scope and appropriate controls.
• Partner with Engineering, Manufacturing, Quality, Automation and other cross-functional groups to execute individual and team-based validation activities.
• Investigate issues, apply root cause analysis and support corrective actions and continuous improvement efforts.
• Provide technical support for project execution, equipment start-up and validation readiness, including potential Factory Acceptance Testing (FAT) activities.
• Maintain clear, inspection-ready technical documentation and support client or regulatory audit activities as needed.
• Build knowledge across aseptic processing, automated visual inspection (AVI), packaging and cold-storage operations, with exposure to equipment platforms such as Optima or IMA where applicable.

• Full-time, onsite role in Greenville, NC, generally Monday through Friday during normal business hours; scheduling can be flexible based on business needs and completion of responsibilities.
• Approximately three months of role-specific onboarding and training, followed by continued learning through hands-on project work and cross-functional exposure.
• Site-wide scope with opportunities to work across a…