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Sr. Automation Specialist Medical Devices - De Pere, United States - Validation & Engineering Group Inc.
Description
Job DescriptionJob 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:
Senior Automation Specialist for Medical Devices
Qualifications:
Bachelor's Degree in Computer Science or Engineering.
Minimum of 8 years of experience in direct pharmaceutical, medical device or biotechnology industries.
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).
Technical Writing skills and investigations processes.
Available to work extended hours, possibility of weekends and holidays.
Experience in Medical Devices, Automation Controls, Design Specifications, Allen Bradley, Software Validation and Design Review.
Must be fully bilingual (English / Spanish) with excellent oral skills.
Must be proficient using MS Windows and Microsoft Office applications.
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