MF01-122721 Validation Specialist - QA Laboratory Job at Validation & Engineering Group
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 for talented, dedicated individuals who are committed to work under the highest standards of ethics to and with expertise in the following area and equipment / instruments:
- Laboratory Equipment Installation, and Operational Qualification
- Centrifuges, Refrigerators, Freezers, Cryos, Incubators, Temperature Control Carts, Cool Storage Rooms, Safety Cabinets, Hoods, and Manual Fillers
Qualifications:
- Bachelor's Degree in Science or Engineering.
- Minimum of 3+ 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, 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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