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Urgent! Validation Engineer Job Opening In Durham – Now Hiring Katalyst HealthCares & Life Sciences

Validation Engineer



Job description


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.


  • Assist 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.


  • Able to react to change and perform other duties as assigned.

  • Requirements:
  • Bachelor's Degree required, prefer program in Sciences or Engineering.


  • Minimum of + 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 CFR Parts , /, ISO , ISO , ISO and ISO .


  • 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.


  • ASQ Certified Quality Engineer desired.


  • Minitab software proficiency, desired.


  • Ability to work independently with strong time management and prioritization skills to handle multiple assignments and interact with project teams.


  • Ability to make decisions regarding product disposition and corrective and preventive action effectiveness.


  • Comfortable in giving direction to accomplish work being executed.



  • Required Skill Profession

    Engineers



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      Unlock Your Validation Engineer Potential: Insight & Career Growth Guide


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