MF02-080221 Validation Engineer for Medical Devices Job at Validation & Engineering Group
Validation & Engineering Group, Inc. (V&EG) is a leading services supplier 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 for talented, dedicated individuals who is committed to work under the highest standards of ethics to and with expertise in the following areas:
- Validation Engineer in Medical Devices
- Develop Validation Reports for New Molds
- Knowledgeable of Capacity Analysis using Minitab
- Analyze statistical data
Qualifications:
- Bachelor's Degree in Science and Engineering
- Minimum of 1+ years of experience in direct pharmaceutical, medical device or biotechnology industries.
- Experience in direct process / manufacturing areas.
- Must be fully bilingual (English / Spanish) with excellent oral and technical writing 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, i.e. FDA guidelines, cGMP, 820, OSHA, 21 CFR Part 11, and other related CFR's, ISPE Good Automated Manufacturing Practice (GAMP).
- Strong knowledge (according to related area) of Computer System Validation, Kaye Validator, Serialization,
- Audits, Utilities, Facilities & Equipment Qualification, Process Validation, Product Transfer, Laboratory Equipment, Method Validation, Automation, Lean Manufacturing, Method Transfer, Packaging Line’s.
- Technical Writing skills and investigations processes.
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