Validation Engineer

7 days ago

Chapel Hill, NC, United States Katalyst Healthcares and Life Sciences Full time
Job Description:
  • Reporting directly to the division Sterilization Quality Engineer Lead, this position involves support for the sterilization operations and product sterility assurance program.
  • This position provides quality guidance for product and process sterility, product resolution decisions, and statistical problem-solving techniques to manufacturing operations and project teams for new product introduction, process improvements, continuous improvements, and validation activities.
  • This position works closely with other functions within the organization (Manufacturing, Laboratory, R&D, Quality Systems, Engineering, Procurement and Marketing) and is responsible for ensuring the sterilization requirements are met for product sterilized to ensure compliance to regulatory, customer and internal standards.
Responsibilities:
  • This position interacts with multiple functional groups within manufacturing and sterilization networks.
  • Supports product sterility assurance and compliance across multiple sites within the Life Sciences division.
  • Serves as the quality representative to support multiple projects within the division.
  • Schedules/coordinates/performs assigned projects, compiles test data, writes summary reports and final reports.
  • Provides validation support including master validation planning, change controls, protocol development, review and approvals, IQ/OQ/PQ execution/support, assist with FMEAs and control plans, assist with documentation in electronic document management system.
  • Lead and support activities related to product changes impacting sterilization equipment/processes and the associated laboratory/functional testing required as part of the validations.
  • Facilitate/support investigations for product and process discrepancies and propose corrective actions to process deviations and customer complaints.
  • ssist with the investigation of Corrective & Preventive Actions (CAPA), providing solutions where possible.
  • Create or modify user documentations that fit the business needs and maintain compliance to the regulatory requirements of the FDA and ISO standards.
  • Ensures compliance to regulatory requirements related to product sterility assurance including annual product reviews, environmental controls, bioburden testing, dose audit maintenance and sterility testing.
  • Serve as a resource for performing internal audits to ensure quality system compliance.
  • Drive improvements to deliver on key quality goals and metrics.
  • ble to react to change and perform other duties as assigned.
Requirements:
  • Bachelor's Degree required, prefer program in Sciences or Engineering.
  • Minimum of 2+ years of quality engineering experience in a highly regulated industry; strongly prefer medical device or pharmaceutical.
  • Direct experience in sterility assurance or product sterilization a plus.
  • Strong knowledge of the regulatory and quality system requirements 21 CFR Parts 820, 210/211, ISO 9001, ISO 13485, ISO 11137 and ISO 11737.
  • Leadership ability to coordinate projects at multiple locations in a multi-functional team environment.
  • Working knowledge of databases and spreadsheet applications to perform necessary tasks for preparing required data analysis, reports, documents and general communication.
  • Knowledge of manufacturing processes and relevant statistical methods for quality assurance.
  • Good understanding of continuous improvement methodologies, including lean, six sigma, statistical applications and validation.
  • Must have proficiency using Microsoft Office, Project, Outlook, and software applications.
  • Demonstrated technical writing skills.
  • Experience with sterilization processes highly preferred.
  • SQ Certified Quality Engineer desired.
  • Minitab software proficiency, desired.
  • bility to work independently with strong time management and prioritization skills to handle multiple assignments and interact with project teams.
  • bility to make decisions regarding product disposition and corrective and preventive action effectiveness.
  • Comfortable in giving direction to accomplish work being executed.

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