Validation Engineer II - GMP & Quality Compliance

ThermoFisher Scientific; Greenville (NC); On-site; USD 80,000 - 110,000; Full time

Job summary

Join Thermo Fisher Scientific as a Validation Engineer II to drive compliance and quality across our pharmaceutical manufacturing and laboratory operations. You will oversee validation strategies and ensure alignment with cGMP, FDA regulations, and industry standards while collaborating with diverse teams to deliver robust validation programs.

The role focuses on executing IQ/OQ/PQ validation, managing projects independently, and maintaining rigorous documentation in a fast-paced, global

Qualifications

• Bachelor's degree in Engineering, Life Sciences, Chemistry, or related technical field (Advanced degree preferred).
• 2 years of validation experience in GMP/regulated environment preferred but not required.
• Experience with IQ/OQ/PQ protocols and execution.
• Experience managing validation projects independently.
• Experience with automation systems and computer system validation.
• Experience with quality management systems and documentation.

Responsibilities

• Ensure compliance, quality, and operational excellence across facilities through validation activities.
• Collaborate with cross-functional teams to execute validation plans and SOPs.
• Maintain thorough validation documentation and traceability across projects.

Skills

cGMP knowledge

FDA regulations

Technical writing

Risk assessment

Data analysis

Clear communication

MS Office

Calibration/metrology

Cleanroom experience

Project management

Statistical analysis

Education

Bachelor's degree in Engineering/Life Sciences/Chemistry

Advanced degree preferred

Job description

Join Thermo Fisher Scientific as a Validation Engineer II to drive compliance and quality across our pharmaceutical manufacturing and laboratory operations. You will oversee validation strategies and ensure alignment with cGMP, FDA regulations, and industry standards while collaborating with diverse teams to deliver robust validation programs.

The role focuses on executing IQ/OQ/PQ validation, managing projects independently, and maintaining rigorous documentation in a fast-paced, global