Environmental Control and Sterilization Process Specialist

hace 6 días


Ciudad Guayana, Estado Bolívar, Venezuela Jabil Circuit A tiempo completo

Key Accountabilities

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The Environmental Control and Sterilization Process Specialist will be responsible for ensuring that all aspects of the sterilization and environmental control processes are in compliance with regulatory requirements and company policies.

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Responsibilities

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  • Supervise the coordination of sample manufacturing for validations and/or revalidations of ethylene oxide, dose audits for radiation, bioburden, ethylene oxide residuals with Planning, Production and Process Quality Control.">
  • Ensure control of the shipment of samples that need to be processed in sterilization centers. For sterility tests, dose audits, post-sterile validations of product and packaging.">
  • Ensure that tests in microbiological or chemical laboratories are executed according to the timeline and commitments of each project.">
  • Evaluate the effectiveness of cleaning programs in the Manufacturing areas, through monitoring of particles and microorganisms and biological load in finished product.">
  • Prepare, control and have the necessary materials to carry out the environmental monitoring necessary to comply with the requirements of the ISO 13485 Quality System, ISO 11135, 21 CFR and other local and corporate requirements, as well as international standards related to environmental control and sterilization.">
  • Work closely with the building and engineering groups regarding planned and unplanned projects that impact manufacturing environmental control.">
  • Supervise environmental control activities at the Jabil Healthcare DR site level.">
  • Execute or coordinate the environmental investigation in case of exceeding the alert and action limits; issuing a technical opinion on the cause of the failure as well as establishing the corresponding corrective and preventive actions and their deployment according to procedures.">
  • Ensure the issuance of monthly environmental reports for evaluation in business units, management review of the Quality System, corrective action meetings (CAPA), Quality reports.">
  • Ensure that CAPAs, NCMRs and customer complaints related to sterilization and environmental control are handled in a timely manner.">
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About this Role

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This role requires strong leadership and communication skills, as well as the ability to work independently with minimal supervision or in a team environment.



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