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:
Engineering Compliance Lead
Qualifications:
Bachelor's Degree in Engineering.
Minimum of 2 years of experience in direct pharmaceutical, medical device or biotechnology industries.
Experience in Engineering 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.
Strong knowledge (according to related area).
Technical Writing skills and investigations processes.
Available to work extended hours, possibility of weekends and holidays.
Responsibilities:
OOS Lead Investigator for utilities, facilities and pest control
Risk Assessment Review
Site Deviations Support
CAPA support
SOP Revisions
Forms optimization project
Change Control / Change Action Owner
Support commissioning and validation deviations/protocols, originator, reviewer, and approver.
New Equipment Data entry in Maximo (Computerized Maintenance Management System)
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