Validation Specialist GA

2 days ago

Duluth, GA, United States Validation & Engineering Group Inc. Full time
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.

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