Validation Engineer

Title : Validation Engineer

Location: Winston-Salem, NC



Work Arrangement: On-site

We are seeking a Validation Engineer to support equipment qualification and validation activities within a regulated medical device manufacturing environment.

• Support equipment qualification and validation activities for medical device manufacturing equipment.
• Develop and execute validation protocols, including IQ, OQ, and PQ .
• Prepare validation plans, protocols, test scripts, and final validation reports.
• Perform validation testing and review results against established acceptance criteria.
• Determine appropriate sample sizes for validation studies and support statistical evaluation of validation data.
• Collaborate with Engineering, Quality, and Manufacturing teams to execute qualification and validation activities.
• Support investigation and resolution of validation-related issues, deviations, and documentation requirements.
• Ensure validation activities comply with applicable FDA, GMP, quality, and company requirements .
• Maintain accurate and complete validation documentation throughout the qualification process.

• Bachelor's degree in Engineering, Science, or a related technical field preferred.
• Strong experience in Validation Engineering , preferably within medical device or other FDA-regulated manufacturing environments.
• Hands-on experience with equipment qualification, IQ/OQ/PQ, validation protocols, and sample size determination .
• Strong understanding of validation documentation, testing, and regulatory compliance requirements.

• Validation Engineering
• Equipment Qualification
• IQ / OQ / PQ
• Validation Protocols
• Sample Size Determination
• Medical Device Manufacturing
• FDA / GMP Compliance
• Validation Documentation
• Validation Testing
• Equipment Qualification & Process Validation