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ATL01-093025 Validation Engineer - Molding, Assembly & Metrology_GA
Validation & Engineering GroupDuluth, GA, USjob_description.job_card.variable_hours_ago
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- serp_jobs.job_card.full_time
job_description.job_card.job_descriptionDevelop 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. Education : Bachelor’s degree in engineering. Certifications (preferred) : ISO 14971, ISO 13485, Six Sigma / Lean (Green / Black Belt), GMP training. Technical Knowledge : 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. Experience in computerized system validation (PLC, HMI). Knowledge of medical device manufacturing (Class II preferred).
Job Description
Job Description
Validation & Engineering Group, Inc. is a leading services supplier providing solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Device industries in the areas of Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other technical services.
- Validation Specialist – Molding, Assembly & Metrology
Location : Johns Creek, GA
Approximate Start Date : November 3, 2025
Approximate Duration : 1 Year
Commitment : Full-time, On-site
Position Overview
We are seeking skilled Validation Specialists with strong CQV experience, particularly in injection molding, assembly processes, and metrology equipment . This is a client-facing, hands-on role requiring technical expertise, attention to detail, and the ability to work independently while collaborating across functions.
Key Responsibilities
Required Qualifications
Injection molding equipment qualification and calibration.
Preferred Qualifications
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Validation Engineer • Duluth, GA, US
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