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Sterilization Validation Lead

Job Description

Job Summary

• This position ensures that the validation processes and validation practices of the sterilization plant, equipment, and support areas are aligned and in accordance with current regulatory standards (ISO, AMMI) and those established by BD to comply with good validation practices (GVP's). 
• Participates actively in receiving customer and health authority audits as well as support the laboratory activities for validation and qualifications efforts.  

Job Responsabilities

• Apply the Validation Toolkit (Processes, computer systems, sterilization) in the protocol creation, review, execution, and closure of validation exercises, checking that the validation methodology and the use of specific tools such as risk analysis and plan development sampling control procedures are properly applied to ensure compliance with BD regulatory standards 

• Gives follow up and ensures the execution of activities of the Validation Master Plan (VMP) supporting the performance of activities, data evaluation, and periodic feedback to validation practitioners, to ensure that the requirements and standards of the validation metrics established by BD are met 

• Supports and ensures compliance with established validation standards, advising the organization's personnel on the editing of protocols and validation reports, reviewing and approving them to maintain and improve the practices and efficiency of validation activities, aligning local practices with corporate initiatives 

• Lead the validation projects presentation in customer audits, regulatory instances, and internal audits.

QMS responsibilities: 

• Gives support to the plant personnel for related change control activities, deviation investigation, CAPA, customer complaints, and risk analysis, through active participation and feedback on validation requirements to ensure that these activities consider the impact on the validated state of the processes and system 

Education and Experience

• Bachelor’s degree in a science field: Engineering, Biomedical Engineering, Microbiology, Chemical Engineering 

• A minimum of one year of experience working in Ethylene oxide sterilization setting (preferred) 

• A minimum of one year experience executing Ethylene Oxide sterilization validation work such as load seeding or load processing 

Knowledge and Skills:

• Basic knowledge in chemicals and kinetic reactions. 

• Knowledge of GMP, FDA, ISO and OSHA requirements highly desirable. 

• Knowledge of Ethylene Oxide sterilizer equipment operation 

BD values equity in the workplace without discrimination for any disability, class, ethnicity, age, religion, gender identity.

Required Skills

Optional Skills

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Primary Work Location

MEX Ciudad Juarez - Esterilización

Additional Locations

Work Shift