Senior Validation Engineer - GMP CQV

Regulatory Jobs; Greenville (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

Thermo Fisher Scientific in Greenville, NC is seeking a Validation Engineer to join the CQV team. You will support commissioning, qualification and validation across equipment, facilities and automation in a highly regulated environment.

You will collaborate with Engineering, Manufacturing, Quality, and Automation to ensure compliant, inspection-ready documentation and successful regulatory audits. A strong background in cGMP and technical writing is essential.

Qualifications

• Bachelor’s degree in Engineering, Life Sciences, Chemistry or a related technical field.
• Minimum of 5 years of relevant validation, CQV, engineering or closely related experience in pharmaceutical/biotech manufacturing or another highly regulated environment.
• Experience developing, reviewing and executing validation or qualification protocols, including IQ/OQ/PQ or equivalent lifecycle documentation.
• Experience with manufacturing equipment, facilities and utilities validation; experience with automation controls or computer system validation is valuable.
• Experience coordinating complex technical activities and working effectively across cross-functional teams.
• Equivalent combinations of education, training, and meaningful work experience may be considered

Responsibilities

• 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.

Skills

Cross-functional collaboration

Technical writing

Problem solving

Project management

Regulatory compliance

Education

Bachelor’s degree in Engineering, Life Sciences, Chemistry or related field

Job description

Thermo Fisher Scientific in Greenville, NC is seeking a Validation Engineer to join the CQV team. You will support commissioning, qualification and validation across equipment, facilities and automation in a highly regulated environment.

You will collaborate with Engineering, Manufacturing, Quality, and Automation to ensure compliant, inspection-ready documentation and successful regulatory audits. A strong background in cGMP and technical writing is essential.