ATL01-093025 Validation Engineer Molding, Assembly & MetrologyGA
ATL01-093025 Validation Engineer Molding, Assembly & MetrologyGA
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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: Bachelors 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).
Employment Type
Full Time
