LL01-250905 CSV Validation Specialist
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Job Location:
New Albany, OH - USA
Monthly Salary:
Not Disclosed
Posted on:
09-09-2025
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:
- CSV Validation Specialist (Lab equipment)
Qualifications:
- Bachelors Degree in Science or Engineering.
- Minimum of 5 years of experience in direct pharmaceutical medical device or biotechnology industries.
- Experience in direct process / laboratory areas.
- Must be fully bilingual (English / Spanish) with excellent oral skills.
- Must be proficient using MS Windows and Microsoft Office applications.
- Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
- Experience in Design Documentation (URS DS) IQ OQ PQ CSV protocols development and execution deviations and reports generation.
- SDLC Risk Assessment Data Integrity Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).
- Strong knowledge of Ellab Data Loggers Star Oddi Sensors Keyence Microscopes Kaye Data Loggers X-Ray Bar Code Verifiers.
- Experience with Kneat CDOCS Maximo.
- Technical Writing skills and investigations processes.
- Available to work extended hours possibility of weekends and holidays.
Required Experience:
Unclear Seniority
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
