Validation Specialist

7 days ago

New Albany, OH, United States Validation & Engineering Group Inc. Full time
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.

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