ATL01-093025 Validation Engineer - Molding, Assembly & Metrology_GA

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

• 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).