ATL01-120825 Validation Specialist GA
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Job Location:
Duluth, MN - USA
Monthly Salary:
Not Disclosed
Posted on:
5 days ago
Vacancies:
1 Vacancy
Job Summary
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
- 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.
- Experience with Kneat.
Required Experience:
IC
Key Skills
- Python
- SOC
- Debugging
- C/C++
- FDA Regulations
- Minitab
- Technical Writing
- GAMP
- OS Kernels
- Perl
- cGMP
- Manufacturing
About Company
Validation & Engineering Group Proudly serving our clients since 1997 Validation & Engineering Group provides world-class service and expertise to the Biotechnology, Food Safety and Quality, Medical Devices, and Pharmaceutical Industries. We offer our clients: Validation, Control Syst ... View more
