What are the responsibilities and job description for the Validation Specialist - Deerfield, FL position 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
- Vision Systems (preferably Cognex)
- Manufacturing, Packaging and Laboratory Equipment
- Commissioning / Qualification
- Computer System Validation (CSV)
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.
- Excellent oral and technical writing skills in English.
- 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 of Computer System Validation & Equipment Qualification.
- Excellent technical Writing skills