Qureos Mentor

Validation & Engineering Group

<div>Validation &amp; Engineering Group, Inc. (V&amp;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:
<ul><li>Validation Specialist
</li></ul>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
<ul><li>Develop and execute validation deliverables including URS, ERES assessments, FAT/SAT protocols, IQ/OQ/PQ, POQ, and traceability matrices.</li>
<li>Plan, manage, and perform equipment qualification and process validation activities following a risk-based CQV approach.</li>
<li>Support qualification of general production and laboratory equipment used in medical device manufacturing.</li>
<li>Apply risk management practices including functional risk documents, assessments, and pFMEAs.</li>
<li>Execute and manage computerized system validation activities (PLC, HMI, Part 11 requirements, and integration testing).</li>
<li>Prepare high-quality validation documentation, circulate for review, and incorporate feedback to ensure right-first-time submissions.</li>
<li>Investigate deviations during execution and manage resolution and documentation of root cause and corrective actions.</li>
<li>Track documentation cycles, deviations, deliverable status, and project progress versus schedule.</li>
<li>Communicate effectively with internal and client teams and escalate challenges that may affect schedule or deliverables.</li>
<li>Provide status updates as required.</li>
</ul>
Required Qualifications
<ul><li>Bachelor&rsquo;s degree in Engineering or Natural Sciences.</li>
<li>3 to five 5 hands-on validation experience, including writing and executing protocols.</li>
<li>Experience with equipment qualification, process validation, and computerized system validation.</li>
<li>Strong understanding of 21 CFR Part 820, 21 CFR Part 11, ISO 13485, and risk-based validation practices.</li>
<li>Proficiency in Microsoft Word, Excel, and Project.</li>
<li>Strong documentation skills, attention to detail, and ability to work independently.</li>
<li>Effective communication and collaboration skills.</li>
<li>Experience with Kneat.</li></ul></div>

ATL01-120825 Validation Specialist GA

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Validation & Engineering Group

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ATL01-120825 Validation Specialist GA