Validation & Engineering Group, Inc. · 1 day ago
ATL01-011326 Validation Specialist GA
Duluth, GA
Contract
Onsite
Senior Level
5+ years expValidation & Engineering Group (VEG) is a specialized consulting firm providing Commissioning, Qualification, and Validation (CQV) services to FDA-regulated industries. VEG is seeking a Senior Validation Consultant to support the validation of a Smart Automated Line Clearance system at a regulated manufacturing site, leading document development and execution activities while collaborating with various teams.
BiotechnologyConsultingProfessional ServicesQuality Assurance
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
Qualification
Required
Bachelor's degree in Engineering or related technical discipline (Mechanical, Electrical, Chemical, Computer Science, or similar)
Minimum 5–7 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
Preferred
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
Company
Validation & Engineering Group, Inc.
Validation & Engineering Group, Proudly serving our clients since 1997.
51-200 employees
Funding
Current Stage
Growth StageTotal Funding
unknown2025-08-06Acquired
Leadership Team
Luis Puig
Partner
Recent News
News is my Business
2025-08-20
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