What are the responsibilities and job description for the LL01-250611 Validation Specialist - Packaging Equipment position 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 a talented, dedicated individual committed to work under the highest ethics standards for the following position:
- Validation Specialist for Packaging Equipment
Qualifications:
- Bachelor's Degree in Science or Engineering.
- Minimum of 3 years of experience in direct pharmaceutical, medical device or biotechnology industries.
- Experience in biotech packaging equipment (Vial filling, Syringe Filling, Lyophilization, Isolators, and secondary packaging such as labelers, cartoner, serialization, inspection).
- Must be fully bilingual (English / Spanish) with excellent oral 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.
- Experience in Commissioning and Design Documentation (URS, DS), IQ, OQ, PQ protocols development and execution, deviations and reports generation.
- SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).
- Technical Writing skills and investigations processes.
- Available to work extended hours, possibility of weekends and holidays.