Validation Engineer

Intellectt INC; Winston-Salem (NC); On-site; USD 80,000 - 110,000; Full time

Job summary

Intellectt INC is seeking a Validation Engineer to support qualification and validation activities for medical device manufacturing equipment. You will develop IQ/OQ/PQ protocols, create validation plans, and generate final reports.

Responsibilities include performing validation tests, determining sample sizes, and collaborating with Engineering, Quality, and Manufacturing to ensure regulatory compliance and robust documentation.

Qualifications

• Bachelor's degree in engineering, science, or related technical field.
• Hands-on experience with equipment qualification and validation activities.
• Familiarity with IQ/OQ/PQ, validation protocols, and data evaluation.

Responsibilities

• 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 to ensure compliance with established acceptance criteria.
• Determine appropriate sample sizes for validation studies and support statistical evaluation of validation data.
• Work 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 all validation activities comply with applicable FDA, GMP, quality, and company requirements.

Skills

Equipment Qualification

Validation Engineering

IQ / OQ / PQ

Sample Size Determination

Validation Protocols

Medical Device Manufacturing

FDA / GMP Compliance

Validation Documentation

Education

Bachelor's degree in Engineering, Science, or related field

Job description

Title:

Validation Engineer

Location

Winston-Salem, NC

Job Description

• 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 to ensure compliance with established acceptance criteria.
• Determine appropriate sample sizes for validation studies and support statistical evaluation of validation data.
• Work 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 all validation activities comply with applicable FDA, GMP, quality, and company requirements.

Education & Experience

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

Skills

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