MF04-102023 Validation Specialist - CSV
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
Provides technical and project leadership.
Develop test method qualification and validation protocols.
Ensure validation master plans comply with regulatory agency requirements.
Support regulatory submissions and regulatory agency inspections as required.
Qualifications:
Bachelor's Degree in Science or Engineering.
Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries.
Strong team leader with project management skills and focus on results.
Must be fully bilingual (English / Spanish) with excellent oral skills.
Must be proficient using MS Windows and Microsoft Office applications.
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.