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LL01-062025 Validation Specialist for Biotech Site
Validation & Engineering Group00777, PR, USHace 12 días
Descripción del trabajoBachelor's Degree in Science or Engineering. Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries. Experience in qualification and validation of facilities, utilities, drug substance, filling, inspection, and / or packaging areas for the Biotechnology industry. 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 protocols development and execution, deviations and reports generation. SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT). Experience with Kneat, CDOCs Technical Writing skills and investigations processes. Available to work extended hours, possibility of weekends and holidays.
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 :
- Validation Specialist
Qualifications :
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Validation Specialist • 00777, PR, US
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