Manager, Sterilization Sciences
POSITION TO BE BASED AT OUR MASON, OH LOCATION. RELOCATION ASSISTANCE AVAILABLE FOR THIS ROLE.
This position will be responsible for the development, implementation, and management of company-wide sterilization and environmental monitoring programs. Works within prescribed GMP/ISO/GLP Standards and ensures compliance to all applicable national and international regulations. Position supports new and existing products and processes carried out in various controlled manufacturing environments, including the broader supply chain.
Provides sterilization and environmental monitoring expertise to both existing manufacturing operations and new product development. Works with manufacturing and development teams to evaluate, develop, and validate appropriate sterilization, cleaning, and environmental monitoring requirements. Position will have the opportunity to support the various global groups and interact with Operations, R&D and technical teams on trending, alert limits, and assessing the impact of manufacturing and design changes. This role has a direct impact on the quality and safety of existing products, as well as, products during design and development.
ESSENTIAL FUNCTIONS OF THE POSITION:
- Builds world class quality system procedures and tools to administer the sterilization and environmental monitoring programs at AtriCure.
- Works within prescribed GMP/ISO/GLP Standards and assures compliance to all applicable regulations
- Provides technical solutions to product development teams and manufacturing using various fields of science and sterilization theory and practice
- Manage sterilization and environmental monitoringl activities by providing leadership and direction to team of engineers, technicians, and / or specialists to ensure company objectives are met in a timely manner.
- Provide leadership, mentoring, and development plans for all direct reports to maintain an engaged and productive workforce.
- Designs, validates and implements sterilization processes taking into consideration sterility assurance, fitness for use, product and packaging functionality, and process compatibility
- Provides support for manufacturing related environmental monitoringevents and sterilization operations, interacting with contract sterilizers and test facilities
- Provides technical guidance on sterilization needs to Product Development on new product and sustaining engineering projects
- Leads manufacturing site environmental monitoringprograms by establishing trend reviews, responding to alerts and assessing impact of changes to products, process, and environment
- Participates in internal and external audits as subject matter expert defending sterilization and environmental monitoringprocesses and activities
- Delivers results and drives continuous improvement. Sets high performance goals and holds self-accountable for results
- Leads projects to optimize sterilization logistics to achieve greater operational efficiencies
- Strong understanding of domestic and international standards and controls which are job related, such as risk management, sterilization, biocompatibility, environmental monitoring, or other areas
- Internal – Manufacturing, Facilities, Operations, Supply Chain, Engineering, Quality Assurance and Regulatory Affairs personnel
- External – Contract sterilizers, contract manufacturers, suppliers of microbiological equipment, laboratory testing services and contract sterilization and environmental monitoring services
ADDITIONAL ESSENTIAL FUNCTIONS OF THE POSITION:
- Regular and predictable work performance
- Ability to work under fast-paced conditions
- Ability to make decisions and use good judgment
- Ability to prioritize various duties and multitask as required
- Ability to successfully work with others
- Additional duties as assigned
- Bachelor’s degree in Microbiology preferred. BA/BS/MS in Biology, Engineering, or related science or demonstrated equivalent combination of education, training and experience.
- Demonstrates knowledge of gamma sterilization and ethylene oxide validation principles and industry standards and experience in sterilization process controls.
- Demonstrates expert technical knowledge of working within a controlled manufacturing environment and has experience in monitoring and maintenance of systems validation of controlled environments using national and international standards
- Have a minimum of five years hands on experience in designing, validating and implementing environmental control evaluations, sterilization processes, and microbial and sterility testing within medical device/pharmaceutical manufacturing.
- Have a working knowledge of GMP/ISO/GLP guidelines as applied to medical device sterilization
- Have hands on experience in monitoring and maintenance of validation of cleaning processes and controlled environments using current guidelines and regulations
- Have provision of scientific data to support manufacturing, resolve non-conforming issues and ensure adequate corrective and preventive actions
- Have general leadership skills to organize complex work schedules
- Have the ability to work with people and teams in a complex, changing environment and be able to deliver value added results to the business on time
- Be fully competent in oral and written communications including strong documentation skills
- Ability to travel 15%
- MS in Microbiology
- Management / Leadership Experience
- FDA and ISO Audit experience
- MDD/ MDR, CMDR, and JPAL knowledge
- ASQ Certified Quality Engineer
- ASQ Certified Quality Auditor
- ASQ Certified Biomedical Auditor
- Ability to regularly walk, sit, or stand as needed
- Ability to occasionally bend and push/pull as needed
- Ability to regularly lift up to 25 pounds, occasionally lift over 25 pounds
- Ability to pass pre-employment drug screen and background check
- Job Family Sterilization & Environmental Controls
- Job Function Quality
- Pay Type Salary
- Employment Indicator People Manager