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in Carolina, PR
MF01-010824 CSV Scientist for QA Lab Equipment
Hours | Full-time, Part-time |
---|---|
Location | Carolina, Puerto Rico |
About this job
Job Description
Job Description
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:
- QA Laboratory Equipment and Software Validation
Qualifications:
- Bachelor's Degree in Science or Engineering.
- Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries.
- Experience with validating mechanical and computerized systems, which includes developing documents from URS, DQ, and DS to IOQ, test plans, risk assessment, DI (Design Input), security plan configuration, and all the necessary documents for validating equipment, adhering to regulatory and plant standards.
- Strong knowledge in cGxP and regulatory guidance as well as understanding of how they are applied to regulatory compliance.
- Technical Writing skills and investigations processes.
- Available to work extended hours, possibility of weekends and holidays.