Edwards Lifesciences Staff Microbiologist, Quality in Irvine, California
The Staff Microbiologist has capabilities for in-depth microbiological/ sterilization validation strategy, related project planning, coordination, execution and testing, technical reports and other documentation, audit presentation, and related regulatory support writing. Emphasis is on EO sterilization for global sites, inclusive of Edwards lifesaving devices and treated tissue valves, future sterilization modalities and antimicrobial treatment.1. The primary responsibilities include the following:
Develop sterilization project plans and documents to deliver sterilization processes for new product or process introduction. Works with team to execute studies to establish sterilization levels and system validation /revalidations for sterility. Partner with cross functional groups and contractors as needed.
Remains abreast of sterilization standards/ guidance and publications for development of technically sound studies, documents, and procedures for Edwards sterilization.
Creates /Reviews protocols, data analysis, and reports related to sterilization. Provides recommendations and collaborates with team. Develops complex methods and defines requirements/ parameters. Contributes ideas, recommends changes, assessment of deviations, interpretations beyond procedural guidelines.
Provide product transfer support related to sterilization.
Leads lab for root cause/corrective action support for excursions within the sterilization process.
Provide support for Regulatory Reviews regarding sterilization and microbiological testing.
- May train, coach, and guide lower level employees on new procedures, assess work techniques and provides feedback on procedures. Works independently. Will serve as a resource (SME) for colleagues with less experience
May have direct reports (up to 2).
Supervises employee activity in an assigned area, overseeing accomplishment of tasks, projects, and operations.
Directs, with some coaching, team members on performance, completes employee performance evaluations, and recommends pay actions.
- Responsible for documentation and implementation of new laboratory method validations and data. Provides recommendations for Continuous Improvement of in-house laboratory methods and validation of laboratory equipment. May consult with external sterilization companies. Drives the development of new and improved systems, processes, methods, for growth, compliance and efficiency. Provide innovative solutions regarding parametric release.4. Create a motivating and trusting environment to drive compliance to ISO 11135, 11137, 14160, 17665 and 17664. Ensure compliance to FDA, EPA and other Regulatory Body standards.5. Conduct external sterilization audits and reviews, and laboratory audits as a subject matter expert.6. Additional responsibilities may be assigned to fulfill business needs. General Qualifications
Minimum of 8 years of sterilization qualification experience.
Bachelor’s degree in Microbiology or a related discipline.
Must have a combination of strong, demonstrated skills including:
Proven technical experience in multiple sterilization techniques such as EtO, Gamma, eBeam and Autoclaving processes.
Capable of developing procedures. Proven record that demonstrates that he/she is adept at creating, directing and implementing plans, subsequently attaining the plan.
Good communication and interpersonal skills to work effectively with all levels of employees, vendors, industry personnel.
Strong ability to develop resources and influence others. Ability to set strategic direction for organization and broadly communicate the vision, strong results orientation and people development skills are essential.
Knowledge in Quality System Regulation, FDA, and ISO regulations.
Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.
Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 13,000 individuals worldwide.
For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.