ATL01-011326 Validation Specialist GA

Validation & Engineering Group • Duluth, GA

7h

About The Position

Validation & Engineering Group (VEG) is a specialized consulting firm providing Commissioning, Qualification, and Validation (CQV) services to FDA-regulated industries, including pharmaceutical, medical device, and biotech manufacturing. VEG supports clients with hands-on technical execution, regulatory compliance, and high-quality documentation, with a strong focus on automation, packaging, and computerized systems. Position Summary VEG is seeking a Senior Validation Consultant to support the validation of a Smart Automated Line Clearance system at a regulated manufacturing site. This role will lead validation document development and execution activities, working closely with Quality, Engineering, Automation, and Production teams. This is a hands-on role requiring strong technical writing skills, independent execution capability, and experience validating automated and computerized systems in a cGMP medical device or pharmaceutical environment.

Requirements

• Bachelors degree in Engineering or related technical discipline (Mechanical, Electrical, Chemical, Computer Science, or similar)
• Minimum 57 years of hands-on validation experience , including protocol authoring and execution
• Experience validating automated equipment and manufacturing systems
• Solid understanding of mechanical and electrical requirements for automated equipment
• Experience with Computerized System Validation (PLC, HMI)
• Strong knowledge of cGMP requirements and Good Documentation Practices
• Ability to work independently with minimal supervision
• Strong technical writing and communication skills
• Proficiency in Microsoft Word, Excel, and Project

Nice To Haves

• Medical device manufacturing experience (Class II preferred)
• Risk-based approach to commissioning and qualification
• Experience supporting cleaning validation activities
• Project engineering or project management experience in cross-functional environments

Responsibilities

• Author and execute validation documentation for a Smart Automated Line Clearance system
• Develop and support the following deliverables: Validation Plan Qualification Needs Assessment URRA / TMX Functional Design Specification Configuration Specification IOQ Validation Summary Report (VSR)
• Generate and update applicable SOPs
• Support deviation investigations, including root cause and impact analysis
• Participate in risk assessments and mitigation strategies
• Serve as liaison between QA, Engineering, Automation, and Production
• Support validation activities related to computerized systems (PLC, HMI) and data integrity requirements (21 CFR Part 11, as applicable)
• Track project progress against schedule and provide routine status updates

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Number of Employees: 101-250 employees