LLValidation Specialist Packaging Lines Equipment

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 Lines Equipment Periodic Review

Qualifications:

• Bachelor's Degree in Science or Engineering.
• Minimum of 5 years of experience in direct pharmaceutical, medical device or biotechnology industries.
• Experience in commissioning, qualification and validation of packaging lines (Carton labeler, autoinjector labeler, buffer accumulator, Cartoner, case packer, palletizer, Systech Sentri vision systems)
• 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 Design Documentation (URS, DS), IQ, OQ, PQ, Periodic reviews protocols development and execution, deviations and reports generation.
• SDLC, Risk Assessment, Data Integrity, Factory Acceptance Test (FAT) & Site Acceptance Test (SAT).
• Strong knowledge in Packaging equipment.
• Technical Writing skills and investigations processes.
• Available to work extended hours, possibility of weekends and holidays.