Delivering on the promise of medical innovation begins at Boston Scientific.
By delivering innovative products that help clinicians improve the lives of patients every single day, Boston Scientific makes a profound impact on the quality of medical care around the world. As we continue to transform the field of medical technology, we seek dedicated individuals who possess the integrity and creative spirit needed to thrive in an innovative company. Join a global organization that is fueled by the diversity and talent of its entire workforce.
Sr. Sterilization Microbiologist
Description
Sr. Sterlization Microbiologist
Position Purpose:
Provide oversight of assigned Sterilization Department objectives and related technical support of Corporate Sterilization objectives.
Customers:
Divisional Manufacturing Team Members, Quality Teams, Research & Development, Contracted Sterilization Companies and Regulatory Affairs.
Expectations:
- Manage the sterilization aspects of process validation using Ethylene Oxide; create and manage Quality Plans as part of the management of sterilization projects; interface with corporate logistics to create priorities for sterilization projects.
- Ethylene oxide deliverables, and sterilization technology direction objectives are set, monitored, and completed in proper priority.
- Consult on sterilization and quality issues, support problem solving and resolution, and provide counsel to customers for related sterilization testing needs.
Scope:
The position reports to the Corporate Sterilization Services Process Validation Manager.
This position is responsible to manage Sterilization and Microbiology related projects in a variety of areas with little direction and need for oversight of time management. The Senior Sterilization Microbiologist will function as a project manager for assigned department programs. This position insures that strategic decisions as well as key technical decisions for sterilization are documented and implemented.
Senior Sterilization Microbiologist is responsible to ensure that all programs and documentation comply with internal/external standards and regulations.
Senior Sterilization Microbiologist is responsible for ensuring that all programs and documentation comply with internal/external standards and regulations.
Senior Sterilization Microbiologist is responsible to Act as the primary contact between Corporate Sterilization Services and Contract Sterilization Vendor
Qualifications/Education/Experience Required:
This position requires knowledge and ability typically associated with a Bachelor's degree in microbiology or related science. Also required is 5+ years of relevant experience such as, regulatory affairs, sterilization experience, knowledge of international standards and at least 1+ years of medical device experience.
Dimensions:
Staff: 0
Other: Strong interpersonal skills required for position.
Principal Accountabilities:
65% Improve and manage validation systems and assure quality and compliance related information and data is accurate, reliable, and supports business objectives.
· Develop, implement and maintain documentation systems, procedures and document formats to support product development programs. Assure compliance with applicable standards, guidelines, corporate policies and regulatory requirements.
· Conduct or assist with sterilization process validations, data analysis, and report generation as required, assuring compliance with applicable standards, guidelines, policies and regulations.
· Assist with the generation of regulatory documentation and review of product submissions.
15% Perform the duties of a sterilization microbiologist for studies conducted by the department to support compliance with operational needs.
10% Participate in Corporate and Departmental projects to ensure sterilization aspects are appropriately represented and minimizes negative regulatory exposure.
10% Set direction for corporation by conducting research and recommending to management and teams more innovative ways to conduct day to day business.
