Sterilization and Environmental Control Manager

At Jabil we strive to make ANYTHING POSSIBLE and EVERYTHING BETTER. We are proud to be a trusted partner for the world's top brands, offering comprehensive engineering, manufacturing, and supply chain solutions. With over 50 years of experience across industries and a vast network of over 100 sites worldwide, Jabil combines global reach with local expertise to deliver both scalable and customized solutions. Our commitment extends beyond business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe.

Job Description

SUMMARY

The Sterilization and Environmental Control Quality Manager supervises and maintains activities related to the control of the sterilization process of medical products, environmental control of clean rooms, as well control of semi-controlled rooms dedicated to the manufacturing of medical products, defining strategies aligned with the philosophy and policies of the organization to achieve compliance with procedures, standards and specifications.

• Supervise the activities of your team in the environmental control and sterilization area of the Jabil Healthcare DR site, ensuring compliance with the procedures of the Quality System and applicable international standards.
• Promote continuous improvement in the plant by applying environmental assessment techniques related to process improvements and maintenance of the Quality System.
• Responsible for maintaining all ethylene oxide chambers revalidated and follow up with the customers when such revalidations must be performed.
• Responsible for developing and executing validation strategies for new products sterilized by ethylene oxide or radiation at the Jabil Healthcare DR site.
• Evaluate the root cause of sterilization and environmental control problems both at local facilities and from customer complaints through the corrective action system and provide support with the departmental teams associated with your areas of responsibility.
• Ensure control and maintenance of compliance with the biological load verification program for gas-sterilized products, as well as dose audits for radiation-sterilized products.
• 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.
• Establish formal and periodic contact with Manufacturing and functional support areas.
• Ensure maintenance of control of files, records and dossiers of the biological load verification program.
• Supervise the activities of your team in the environmental control and sterilization area of the Jabil Healthcare DR site, ensuring compliance with the procedures of the Quality System and applicable international standards.
• Promote continuous improvement in the plant by applying environmental assessment techniques related to process improvements and maintenance of the Quality System.
• Responsible for maintaining all ethylene oxide chambers revalidated and follow up with the customers when such revalidations must be performed.
• Responsible for developing and executing validation strategies for new products sterilized by ethylene oxide or radiation at the Jabil Healthcare DR site.
• Evaluate the root cause of sterilization and environmental control problems both at local facilities and from customer complaints through the corrective action system and provide support with the departmental teams associated with your areas of responsibility.
• Ensure control and maintenance of compliance with the biological load verification program for gas-sterilized products, as well as dose audits for radiation-sterilized products.
• 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.
• Establish formal and periodic contact with Manufacturing and functional support areas.
• Ensure maintenance of control of files, records and dossiers of the biological load verification program.
• Comply and follow all procedures within the company security policy.

• Professional in the area of science, chemistry, Microbiology, Chemistry engineering or any of the chemical or biological sciences preferably.
• Knowledge of sterilization and environmental standards ANSI AMMI ISO 11135, ANSI AAMI ISO 11137 and ISO 14644.
• Current knowledge of QSR- 21 CFR Part 820, ISO 13485 Quality System standards,
• Internal auditor, preferred.
• Quality Engineer certified by the American Society of Quality, preferred.
• Biomedical auditor certified by the American Society of Quality, preferred.
• Certified Six Sigma Green Belt or above, preferred.
• Lead auditor in ISO 13485 and clinical testing laboratory standards, preferred.
• Ability to work independently, with minimal supervision or in a team environment.
• High degree of cultural sensitivity due to the multinational mix of the workforce.