ATL01-120825 Validation Specialist GA

Validation & Engineering Group•Duluth, GA

12d•Onsite

About The Position

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.

Requirements

Bachelors 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.

Nice To Haves

Experience with Kneat.

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.