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)