MF01-080221 Validation Specialist 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:
- Automation Resource for Validation of Medical Devices Assembly Machine
- Development of Validation Plan (VP) [URS and FDS are available]
- Standard Operational Procedures (SOPs)
- Qualification Protocol development, execution, and report
Qualifications:
- Bachelor's Degree in Science and Engineering
- Minimum of 5+ 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 5).
- Technical Writing skills and investigations processes.
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