Sr. Sterilization Engineer - Tijuana, México - Mammotome
Descripción
Sterilization Engineers are responsible for providing technical expertise and business leadership to engineering, operations, regulatory teams in sterilization and microbiological areas.
The basic function of the Sterilization Engineer at the manufacturing site is to plan, coordinate and direct the sterilizatio program to ensure continuous accomplishment of regulations regarding Sterilization activities, consistent with established standards by performing the following duties:
Own the process for conducting routine and periodic testing related to Radiation (Routine Dose Audits & Bioburden tests) and EtO (Bioburden and process requalification activities) sterilization standards at the manufacturing facility.
Responsible for coordinating and submitting device sample requests to manufacturing, shipping samples to sterilizer/external laboratories, and coordinate processing of samples (sterilization and laboratory testing - e.g bioburden, endotoxin, EO residuals, dose audits, method suitability).
Collaborate with New Product Development (NPD) teams, sustaining teams, and VAVE teams for effective transfer of sterilization deliverable from initial sterilization validations to routine processing and monitoring.
Provide sterilization change impact assessments on commercialized products related to manufacturing site specific changes, and execute any required testing, test protocol and reports generation.
Support quality & regulatory assurance objectives and coordinate with related areas of production procedures, and in cooperation with other engineers/supervisors to maximize product reliability, adherence to regulation and to minimize costs.
Plan, promote, and organize training activities related to Good Manufacturing Practices, and Sterilization matter to improve bio-contamination control at the manufacturing facility.
Responsible and participate in external sterilizer or microbiological lab audits, and participate in internal or notified body audits as the manufacturing sterilization SME.
May supervise or other engineering or technical roles.
When you join us, you'll also be joining Danaher's global organization, where 80,000 people wake up every day determined to help our customers win.
As an associate, you'll try new things, work hard, and advance your skills with guidance from dedicated leaders, all with the support of powerful
Danaher Business System tools and the stability of a tested organization.
At Danaher, we value diversity and the existence of similarities and differences, both visible and not, found in our workforce, workplace and throughout the markets we serve.
If you've ever wondered what's within you, there's no better time to find out.
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