ATL01-120825 Validation Specialist GA

Validation & Engineering Group, Inc. (V&EG) is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Validation Specialist
  
  

Location: Johns Creek, GA

Approximate Start Date: February 2026

Approximate Duration: 4 months to 1 Year

Commitment: Full-time, On-site

Position Overview

We are seeking a Validation Specialist with strong CQV experience, preferably within medical device manufacturing. This is a client-facing, hands-on role that requires technical depth, independent work, and effective collaboration with cross-functional teams. The role focuses on general equipment qualification activities supporting the site platforms.

Key Responsibilities

• Develop and execute validation deliverables including URS, ERES assessments, FAT/SAT protocols, IQ/OQ/PQ, POQ, and traceability matrices.
• Plan, manage, and perform equipment qualification and process validation activities following a risk-based CQV approach.
• Support qualification of general production and laboratory equipment used in medical device manufacturing.
• Apply risk management practices including functional risk documents, assessments, and pFMEAs.
• Execute and manage computerized system validation activities (PLC, HMI, Part 11 requirements, and integration testing).
• Prepare high-quality validation documentation, circulate for review, and incorporate feedback to ensure right-first-time submissions.
• Investigate deviations during execution and manage resolution and documentation of root cause and corrective actions.
• Track documentation cycles, deviations, deliverable status, and project progress versus schedule.
• Communicate effectively with internal and client teams and escalate challenges that may affect schedule or deliverables.
• Provide status updates as required.
  
  

Required Qualifications

• Bachelor’s degree in Engineering or Natural Sciences.
• 3 to five 5 hands-on validation experience, including writing and executing protocols.
• Experience with equipment qualification, process validation, and computerized system validation.
• Strong understanding of 21 CFR Part 820, 21 CFR Part 11, ISO 13485, and risk-based validation practices.
• Proficiency in Microsoft Word, Excel, and Project.
• Strong documentation skills, attention to detail, and ability to work independently.
• Effective communication and collaboration skills.
• Experience with Kneat.