Olympus America Inc. Senior Microbiologist, Sterilization in Southborough, Massachusetts
Southborough, MA; Bartlett, TN; or Brooklyn Park, MN - The Senior Microbiologist, Sterilization is responsible for providing Sterilization Microbiological expertise to the Olympus Surgical Technologies America group and ensuring that the Operational and Development activities in regards to cleaning, disinfection, and sterilization are in compliance with internal and external requirements and regulations. EOE Minorities/Females/Veterans/Disabled
Provide guidance for the design, layout, construction, control and monitoring of controlled areas.
Ensure that a common and appropriate level of control is adopted throughout the Group and subsidiary companies.
Author Cleaning, Disinfection, and Sterilization validations for new or existing products.
Ensure best practice are being followed for environmental monitoring, trending and adverse event reporting.
Make certain that appropriate techniques, analysis and action plans are developed, documented and implemented.
Develop controls that provide reliable and secure environmental areas, hygiene and manufacturing practices.
Participate in vendor evaluation, verifying the controls for patient contact and controlled-environment entry parts to minimize the risk to the manufacturing operation and patient through the use of contaminated supplies.
Carry out initial review and routine evaluation of Cleaning, Disinfection, and/or Sterilization contractors.
Carry out initial review and routine evaluation of laboratories conducting sterilization, environmental or microbiological services, to ensure that laboratories provide reliable results and meet regulatory and internal expectations.
Perform audits of Olympus OSTA sites to ensure that best practice is being maintained in controlled areas and establish that pertinent activities are effectively implemented.
Provide Microbiological and Good Hygiene Practice training for Olympus OSTA staff.
Ensure new products are design and evaluated for cleanliness, disinfection and sterilization.
Lead and/or assist in the investigation of Cleaning and/or Sterilization related complaints.
Perform all other essential duties as directed.
(ONLY QUALIFIED CANDIDATES WILL BE CONSIDERED)
Bachelor’s Degree in Science/Engineering/Biomedical is required. Master's or higher degree in microbiology is preferred.
Minimum of 7 years of experience in Cleaning, Disinfection, and Sterilization within an FDA regulated medical device environment is required.
Thorough knowledge of hospital infection control practices, including cleaning, high level disinfection and sterilization procedures is preferred.
Past experience or previous input into product design preferred for cleanliness, disinfection and sterilization is essential.
Good communication skills and writing skills are necessary.
Familiarity with pertinent FDA, CDC, AAMI, OSHA and ASTM regulations and guidelines is desired.
Must be able interact to some degree with almost every department in the company.
Most often interacts with upstream quality assurance, research & development, regulatory, and manufacturing.
Must be able to have some contact with customers, consultants, surgeons, product users, patients, and suppliers.
Must be able to travel, domestically and internationally.
Ability to work directly with manufacturing and research & development engineering in evaluation of prototypes for new product, modifications, and/or improvements is necessary.
Ability to work with manufacturing in implementation of new or revised products is essential.
Must be able to manipulate microsize components with fingers.
Use of hands and arms to operate computer, printer, telephone, and develop drawings is necessary.
Ability to see miniature and microsize components, as well as, use of magnifying devices and microscopes is essential.
Auto req ID 2520BR
Posting Title Senior Microbiologist, Sterilization
Company URL Olympus Surgical Technology America at http://www.olympus-osta.com/
About Us Olympus Surgical Technology America is a dynamic medical device company whose vision is to anticipate the needs of surgeons through powerful see and treat procedure solutions that are safe, simple, cost efficient and produce the highest quality patient outcomes. Olympus Surgical Technology America is focused on Minimally Invasive procedures in Urology, Gynecology, General Surgery and ENT. Olympus Surgical Technology America believes its people are its greatest asset. We offer an environment that challenges everyone to grow, contribute, excel and share successes. Olympus Surgical Technology America is committed to creating a world class company with world class people. Olympus Surgical Technology America at http://www.olympus-osta.com/
Posting Locations Massachusetts, Southborough
Minnesota, Brooklyn Park