ATLValidation Specialist GA

ATL
01-120825 Validation Specialist GA

Join to apply for the Validation Specialist role at Validation & Engineering Group, Inc.

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.

Location: Johns Creek, GA |
Approximate

Start Date:

February 2026 |
Approximate Duration: 4 months to 1 Year |
Commitment: Full‑time, On‑site

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.

• 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 escape challenges that may affect schedule or deliverables.
• Provide status updates as required.

• Bachelor’s degree in Engineering or Natural Sciences.
• 3 to five years 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.

Mid‑Senior level

Full‑time

Strategy/Planning and Information Technology