Validation & Engineering Group Inc.
Validation Engineer - Molding, Assembly & Metrology_GA
Validation & Engineering Group Inc., Duluth, Georgia, United States, 30155
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
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. Required Qualifications
Education : 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).
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
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. Required Qualifications
Education : 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).