A Sterilization and Environmental Specialist is responsible for supporting sterility assurance company-wide while maintaining compliance with regulatory requirements and CONMED policies and procedures. Coordinate Ethylene Oxide (EO) and GAMMA dose settings/audits/annual assessments and validations, inclusive of protocols and final reports completed within established time frames. Oversee environmental monitoring of the Utica manufacturing-controlled areas, to include trending analysis and driving improvements. Maintain the bioburden sampling program, inclusive of trending and analysis. Support new product development and product transfers from the sterilization perspective. Act as liaison with contract labs and sterilizers.Job Responsibilities:
- Act as site departmental representative for sterilization and environmental
- matters and develop into the site Subject Matter Expert.
- Assist management in department planning, including staffing and budgeting.
- Remain knowledgeable and current with applicable regulations, standards, and
- guidance documents.
- Interface with, and provide support to, Quality Engineering, Product
- Development Engineering, Manufacturing, Safety, Regulatory and Compliance
- departments regarding sterilization.
- Determine testing requirements for sterilization validations; and coordinate
- testing with contract sterilizers, testing laboratories, and Laboratory Services.
- Validate, from protocol to final report, contract sterilizers, products, material
- and process changes.
- Define, in collaboration with R&D and Lab Services, testing requirements for
- products modified due to supplier changes, cost-improvement projects, etc.
- Participate in audits for domestic and international compliance.
- Disposition sterilization non-conformance's in collaboration with the Lab
- Services team; work with contract sterilizer to determine cause and define and
- implement corrective actions.
- Supports continuous improvement activities on an as needed basis.
- Represent Laboratory Services on product development teams. Maintain
- records using good documentation practices.
- BA/BS degree in microbiology, chemistry, biomedical engineering or a course of study with demonstrated relevance to sterilization and environmental sciences.
- Preferred Experience: Industry experience having an applied knowledge of ISO13485, FDA 21CFR820, and/or other regulations and standards. Working knowledge of aseptic technique in a laboratory setting. Cell culture experience.
- Competitive compensation
- Excellent healthcare including medical, dental, vision and prescription coverage
- Short & long term disability plus life insurance -- cost paid fully by CONMED
- Retirement Savings Plan (401K) -- company match dollar for dollar up to 7% Employee stock purchase plan -- allows stock purchases at discounted price
- Tuition assistance for undergraduate and graduate level courses
CONMED is an Equal Opportunity Employer & an Affirmative Action Employer. CONMED is a strong advocate of workforce diversity. All qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
If you feel you need a reasonable accommodation pursuant to the ADA, you are encouraged to contact us at 800-325-5900 option #3.