LL02-020924 Sr. Automation Specialist [Medical Devices]
Hours | Full-time, Part-time |
---|---|
Location | Juana Diaz, Puerto Rico |
About this job
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:
- 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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Full-time Jobs Part-time Jobs Posting ID: 931835804 Posted: 2024-04-30 Job Title: Senior Automation Specialist