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Company: Fresenius Kabi
Location: Wilson
Posted on: May 13, 2022

Job Description:

Responsible for providing technical support to operations in terms of equipment/system initial validation and equipment/system requalification. Will participate in equipment improvement teams charged with enhancing the compliance and performance of plant systems, while considering the regulatory requirements for change control. Individual must also coordinate HEPA filter integrity/velocity testing and critical area airflow pattern testing. The individual must have a comprehensive understanding of cGMPs and become certified to enter controlled areas of the plant.
Provides direction through direct or indirect supervision to validation team members and contractors as necessary.ResponsibilitiesPRINCIPAL ACTIVITIES PERFORMED BY THE INCUMBENT

  • Schedules and participates in equipment requalifications per Standard Operating Procedures (SOPs).
  • Coordinates and communicates all testing with affected functional groups, where applicable, and evaluates test results.
  • Approves final report and/ or assembles and circulates for approval when necessary.
  • Executes validation studies, or acts as a Project Manager and/ or Technical Reviewer, for equipment to include protocol preparation, scheduling, protocol execution, and final report preparation.
  • Presents results to Regulatory Agency when necessary.
  • Programs, leads and/ or operates department instruments (such as temperature/humidity dataloggers) to perform controlled temperature/humidity chamber qualifications (examples lyophilizers, warehouses, sterilizers, incubators, etc.).
  • Develops/improves validation programs as needed to remain current with cGMPs and industry standards.
  • Schedules and executes, when applicable, HEPA Filter and critical area testing per SOP, and airflow pattern testing.
  • Programs, leads, and/or operates test equipment such as smoke generators, photometers, velocity meters, etc., and accurately records and evaluates results.
  • Represents Validation department in teams assembled to specify, install, validate, troubleshoot and maintain systems and equipment.
  • Conducts Validation deviations and/or participates in deviation investigations to identify root causes and define corrective and/or preventative actions (CA/PA)REQUIREMENTS
    • B.S. degree in Engineering, Science or related area of study;
    • 3-5 years of related experience in a cGMP facility.
    • Generation of reports, deviations or other technical documents.
    • Installation, Operational and Performance Qualification protocol generation and execution.
    • PC literate with standard office application (Word, Excel, PowerPoint, Project, Access) competency.
    • Knowledge and understanding of cGMPs, industry guidance, and aseptic techniques.
    • Understanding of statistical analysis tools and methods.
    • Knowledge of cGMP room classifications, HEPA filter testing and Airflow Pattern testing tools and techniques.
    • Knowledge and experience in cGMP CA/PA, root-cause analysis, risk assessment and investigation tools and techniques.Additional InformationWe offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance, disability, 401K with company match, and wellness program.Fresenius Kabi is an Equal Opportunity/Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.

Keywords: Fresenius Kabi, Wilson , SR VALIDATION ENGINEER, Engineering , Wilson, North Carolina

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