JOB SUMMARY

Performs internal validation activities for sterilization processes using ethylene oxide, E-beam and gamma radiation, as well as requalification of sterilization cycles according to applicable standard specifications.He participates in the release of sterilized product, product disposition, and supervises compliance with environmental control requirements in cleanrooms, consistently ensuring adherence to the Jabil Quality System.

ESSENTIAL DUTIES AND RESPONSIBILITIES

• Responsible for coordinating and executing ethylene oxide, gamma radiation, and E-beam radiation sterilization validation processes following ISO 11737, ISO 11135, ISO 11137, and ISO 11138 standards, as well as creating the required protocols and reports.
• Responsible for coordinating activities related to the revalidation of ethylene oxide chambers and following up with the client when such revalidations need to be performed.
• Responsible for coordinating activities related to changes in finished product components where Jabil Healthcare is responsible for sterilization.
• Internal coordination of the manufacturing and inoculation of samples necessary to carry out sterilization validations and revalidations.
• Evaluating the root cause of sterilization and environmental control problems, both in local facilities and from customer complaints, through the corrective action system and providing support to departmental teams associated with their areas of responsibility.
• Ensuring the control and maintenance of compliance with the biological load verification program for products sterilized by ethylene oxide, as well as dose audits for products sterilized by radiation.
• Ensuring the control of the shipment of samples that need to be processed in the sterilization centers and following up on shipments to the validated testing laboratory for the execution of sterility tests, dose audits, and post-sterilization product and packaging validations.
• Participating in and providing support during internal audits when required.
• Providing support during customer, corporate, or third-party audits when required.
• Creating and following up on Non-Conformities and incidents in the sterilization centers, as well as opening applicable NCMRs and corrective actions.
• Assisting in the review and preparation of the documentation required to maintain compliance with ISO 13485 and QMS.
• Providing support in cleanroom recertification activities as required.
• Reviewing and updating departmental procedures as required.
• Inform the management staff about events that warrant placing product on "hold," non-conforming products or materials, or report non-conforming activities or processes for immediate corrective and preventive action.
• Teamwork: Participate with Production cells, Process Quality, and the Human Resources/Training department in the development of an internal team system that will support preventive and corrective actions of the Quality System.
• Support, perform, and/or coordinate any other work activity requested by the immediate supervisor due to company needs.
• Collect, organize, structure, and write documented material and regulatory information in an understandable and useful manner.
• Support all company Safety, Health, Environmental, and Quality programs and initiatives.
• Understand and apply the Quality Policy.
• Support all programs and initiatives related to the Code of Ethics, Jabil Healthcare Values, and sustainability programs.
• Complete all training requirements according to the Training Matrix and the Quality Management System, including training identified in the training needs assessment, and attend all training sessions when participation is required.

JOB QUALIFICATIONS

• Lean Bronze Certification

• Skill Matrix: Knowledge of environmental monitoring activities.

• Knowledge of sterile product release activities.

• Knowledge of laboratory testing methods and results.

• Knowledge of cleanroom regulations.

• Basic knowledge of gas sterilization regulations.

• Basic knowledge of radiation sterilization regulations.

KNOWLEDGE REQUIREMENTS

• Professional in the field of science, chemistry, biochemistry engineering, or one of the chemical or biological sciences is preferred.
• Excellent verbal and written communication skills (Spanish and English).
• Ability to work independently, with minimal supervision, or in a team environment.
• High degree of cultural sensitivity due to the multinational nature of the workforce.
• Proactive problem-solving skills.
• Extensive knowledge of how to develop biological load control and dose quality auditing for the manufacturing process.
• Strong written and oral communication skills.
• Proficiency in Microsoft Office, Minitab.
• Ability to effectively present information and respond to questions from groups of managers, clients, customers, and the general public.
• Ability to define problems, collect data, establish facts, and draw valid conclusions.
• Ability to compute rate, ratio, and percent and to draw and interpret graphs.

Jabil, including its subsidiaries, is an equal opportunity employer and considers qualified applicants for employment without regard to race, color, religion, national origin, sex, age, disability, genetic information, veteran status, or any other characteristic protected by law.

TEN CUIDADO CON LOS FRAUDES: Las oportunidades laborales legítimas en Jabil se pueden encontrar en nuestro sitio web oficial Jabil.com. Ningun solicitante debe pagar para acceder a estas oportunidades de empleo. Al postularte para un empleo en Jabil, serás contactado a través del portal oficial de jabil por un correo electrónico con teminacion @jabil.com; llamada telefónica directa de un integrante del equipo de Jabil; o correo electrónico directo con una dirección de correo electrónico @jabil.com. Jabil no solicita pagos para realizar entrevistas ni en ningún otro momento durante el proceso de contratación. Jabil tampoco pedirá información personal de identificación como número de seguro social, acta de nacimiento, información de institución financiera, número de licencia de conducir o información de pasaporte por teléfono o correo electrónico. Si crees que estás siendo víctima de robo de identidad o fraude, repórtalo a la policía en los siguientes números y repórtala en el sitio web donde la encontraste. Llama a: 911 o 089.

Accommodation Statement

If you are a qualified individual with a disability, you have the right to request a reasonable accommodation if you are unable or limited in your ability to use or access Jabil.com/Careers site as a result of your disability. You can request a reasonable accommodation by sending an e-mail to Always_Accessible@Jabil.com with the nature of your request and contact information. Please do not direct any other general employment related questions to this e-mail. Please note that only those inquiries concerning a request for reasonable accommodation will be responded to.