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ATL01-093025 Validation Engineer - Molding, Assembly & Metrology_GA
ATL01-093025 Validation Engineer - Molding, Assembly & Metrology_GAValidation & Engineering Group, Inc. • Duluth, GA, US
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ATL01-093025 Validation Engineer - Molding, Assembly & Metrology_GA

ATL01-093025 Validation Engineer - Molding, Assembly & Metrology_GA

Validation & Engineering Group, Inc. • Duluth, GA, US
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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

  • 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).

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    Validation Engineer • Duluth, GA, US