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Sterility Assurance / Validation Associate III
at Renaissance Pharmaceuticals
Lakewood, NJ

Sterility Assurance / Validation Associate III
at Renaissance Pharmaceuticals
Lakewood, NJ

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Sterility Assurance / Validation Associate Overview

This Sterility Assurance / Validation Associate position is responsible for generating and executing protocols and generating final reports to support the qualification/validation and re-qualification of various sterilization processes, including: Steam-in-Place, autoclave loads, Vapor Hydrogen Peroxide (VHP) decontamination processes, dry heat sterilization, depyrogenation tunnels, Media fills, EMPQ, and in-process sterilizing filters. The individual will be expected to execute qualification and re-qualification projects with little or no guidance. This will include the scheduling and staffing requests for protocol execution activities in conjunction with Operations and Quality, coordinating testing with internal and external test laboratories, review and tabulation of results, and report generation and tracking and scheduling re-qualification activities.

Sterility Assurance / Validation Associate Responsibilities

  • Author qualification and validation protocols and reports
  • Develop Design of Experiments (DOEs), develop statistical sampling plans, assess and approve quality attribute requirements, as well as performing statistical analysis and evaluation of data to draw technical conclusions and make decisions.
  • Execute and analyze Steam-in-Place, Autoclave, Vapor Hydrogen Peroxide (VHP) decontamination, dry heat sterilization, depyrogenation tunnels, bulk product sterilization qualification and re-qualification studies
  • Program, utilize, calibrate, and assemble the Kaye Validator/Thermocouple system.
  • Execute change control requirements for validation
  • Statistical analysis of process capabilities
  • Coordinate related validation projects with Planning, Operations, and other relevant departments as needed
  • Represent the department in interactions with other departments as well as internal and external clients in various settings such as meetings, teleconferences, e-mails, printed reports, etc.
  • Subject Matter Expert (SME) on several sterilization and depyrogenation activities as they relate to the Sterility Assurance/Validation group

Sterility Assurance / Validation Associate Qualifications

  • Bachelor's degree in science or engineering from a four-year college or university combined with a minimum of six years related experience and/or training; or equivalent combination of education and experience.
  • Certified Quality Engineer and prior experience in aseptic manufacturing qualification preferred.
  • Must be proficient with Microsoft Word and Excel. Knowledge of Industry Guidance Publications and recommendations related to sterilization, depyrogenation, SIP, VHP, and other relevant disciplines.
  • Must have a minimum of three years experience in EMPQ

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