Sr. Sterilization Engineer

hace 1 mes

Tijuana, México Mammotome A tiempo completo

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).

Receive and analyze sterilization process certificates and laboratory testing and writing of internal protocols and reports and submit documents for approvals per requirements of ISO 11137, ISO 11135 and ISO 11737. Receive, review, analyze, and track sterilization results from sterilizer contractors (Radiation and EtO) to ensure all parameters met required specifications/requirements and assist to Final Release Department to release sterile products per Device History Record (DHR) requirements

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.

Conduct root cause investigations and resolve any incidence related with Sterilization or Environmental issues for Nonconformances, Deviations or CAPAs. Coordinate efforts to reduce incidences and maintain under control Sterility program and Pyrogenicity and 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.

Prepares periodic and special reports concerning departmental activities, problems, subcontractor’s quality system, schedules and rejected items.

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. Our associates, customers and shareholders contribute unique and different perspectives as a result of these diverse attributes.

If you’ve ever wondered what’s within you, there’s no better time to find out.

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