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Quality Assurance Validation Expert

2 months ago

Columbus, Ohio, United States Azzur Group Full time
About the Role

Azzur Group is a leading provider of GxP compliance and consulting services to the life science industry. We are seeking a highly skilled Validation Specialist to join our team of experts.

Key Responsibilities
  • Document Development: Create and maintain procedures, investigations, protocols, reports, and change controls to support our clients' Maintenance and Engineering, Validation, Quality, and Regulatory departments.
  • Validation Life Cycle Documentation: Generate documentation for cleaning, sterilization, shipping, and process validation, as well as facilities, utilities, systems, and equipment qualification/requalification.
  • Technical Writing: Develop and revise a variety of Installation, Operation, and Performance qualification/verification related documents, including SOPs, validation/verification master plans, guidelines, and execution plans.
  • On-Site Support: Provide on-site or support work for clients under supervision, including validation protocol execution, thermal mapping, equipment qualification test execution, investigations, and deviations.
Qualifications and Experience
  • Education: Bachelor's Degree in engineering, science, or a related field, or equivalent experience. A Master's Degree is preferred.
  • Experience: 2-8 years of experience in validation services in a regulated, manufacturing environment within the biotechnology, pharmaceutical, or medical device industry.
  • Skills: Experience in executing protocols, including systems such as Process Validation, utilities, manufacturing equipment, and basic knowledge of laboratory validation.
  • Regulatory Knowledge: Working knowledge of FDA and cGMP regulations and documentation practices.
  • Technical Skills: Ability to read and interpret Piping and Instrument Diagrams (P&IDs) and electrical diagrams.