Validation Specialist / Engineer (EBR)
- Full-time
Company Description
Validation & Engineering Group (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.
Job Description
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:
- Computer System Validation (CSV)
- Electronic Batch Record
- Manufacturing, Packaging and Laboratory Equipment
- Commissioning and Qualification
- Technical Writing
- Process Validation
- Validation Life Cycle (IQ/OQ/PQ)
- Develop and execution of validation protocols
Qualifications
- Bachelor's Degree in Science or Engineering
- 3 to 5 years of experience in pharmaceutical, medical device or biotechnology industries with at least 1 year of experience in Electronic Batch Record
- 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 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.
- Strong knowledge of Computer System Validation
- Technical Writing skills and investigations processes a must
- Available to work extended hours and rotating if necessary
Additional Information
Positions available for Puerto Rico.
Validation and Engineering Group, Inc. is an Equal Employment Opportunity employer.