Ll01-062025 Validation Specialist For Biotech And Aseptic Process

Validation & Engineering Group

Juncos, PR
Permanente
Tiempo completo

Hace 8 días

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 SpecialistQualifications:Bachelor'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
Strong Knowledge in Media Fills, Aseptic Techniques, EMPQ.
Experience in Bioreactors, Fermentators, Aseptic Fill Finish, Filtration Systems, Centriguges.
Experience in Cleaning & Sterility Equipment such as Autoclave, CIP.
Experience in Environmental Control such as Laminar Flow, EMPQ.
Technical Writing skills and investigations processes.
Available to work extended hours, possibility of weekends and holidays.

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