ATL01-120825 Validation Specialist GA at Validation & Engineering Group

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 GAApproximate Start Date: February 2026Approximate Duration: 4 months to 1 YearCommitment: Full-time On-sitePosition OverviewWe 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 ResponsibilitiesDevelop 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 QualificationsBachelors 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.Required Experience:IC Key Skills Python,SOC,Debugging,C/C++,FDA Regulations,Minitab,Technical Writing,GAMP,OS Kernels,Perl,cGMP,Manufacturing Employment Type : Full Time Experience: years Vacancy: 1