ATL01-093025 Validation Engineer - Molding, Assembly & Metrology_GAValidation & Engineering Group, Inc. • Duluth, GA, US
ATL01-093025 Validation Engineer - Molding, Assembly & Metrology_GA
Validation & Engineering Group, Inc. • Duluth, GA, US
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job_description.job_card.job_descriptionEducation : Bachelor's degree in engineering. Certifications (preferred) : ISO 14971, ISO 13485, Six Sigma / Lean (Green / Black Belt), GMP training. Technical Knowledge : Injection molding equipment qualification and calibration. Manual and automated assembly processes (robotics, conveyors, PLCs, servo controls). Metrology systems, calibration, and Gage R&R. MES / SCADA systems in FDA-regulated environments. Regulatory Knowledge : 21 CFR Part 820 (FDA QSR), EU MDR 2017 / 745, ISO 9001, ISO 13485. Skills : Documentation and report writing, problem-solving, root cause analysis, cross-functional collaboration. Tools : Experience with Kneat software is highly desirable. Preferred Qualifications : Experience in computerized system validation (PLC, HMI). Knowledge of medical device manufacturing (Class II preferred).
Overview
Validation Engineer – Molding, Assembly & Metrology_GA
Location : Johns Creek, GA
Approximate Start Date : November 3, 2025
Approximate Duration : 1 Year
Commitment : Full-time, On-site
Validation & Engineering Group, Inc. is a leading services provider serving the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Device industries in Laboratory, Compliance, Computer, Engineering, Validation, and other technical services.
Responsibilities
- Develop and execute validation deliverables including URS, ERES assessments, FAT / SAT protocols, IQ / OQ / PQ, POQ, and traceability matrices.
- Support qualification of molding units, assembly equipment, metrology instruments, handling systems, injection molding tools, and ISO 7 cleanrooms.
- Contribute to facility qualification activities and ensure compliance with regulatory standards.
- Assist in data handling, integration testing, and MES / SCADA system qualifications.
- Collaborate with design, manufacturing, and quality teams to ensure successful project execution.
- Prepare and maintain high-quality validation documentation.
- Provide training and technical support as needed.
Qualifications
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Validation Engineer • Duluth, GA, US
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