Microbiologist III, Sterility Assurance

Vantive is a vital organ therapy company on a mission to extend lives and expand possibilities for patients and care teams everywhere. For 70 years, our team has driven meaningful innovations in kidney care. As we build on our legacy, we are deepening our commitment to elevating the dialysis experience through digital solutions and advanced services, while looking beyond kidney care and investing in transforming vital organ therapies.

Greater flexibility and efficiency in therapy administration for care teams, and longer, fuller lives for patients- that is what Vantive aspires to deliver.

We believe Vantive will not only build our leadership in the kidney care space, it will also offer meaningful work to those who join us. At Vantive, you will become part of a community of people who are focused, courageous and don't settle for the mediocre. Each of us is driven to help improve patients' lives worldwide. Join us in advancing our mission to extend lives and expand possibilities.

Your Role

The Microbiologist III will report to the MN Microbiology Laboratory Manager and be responsible for the laboratory testing including but not limited to microbiological testing, moist heat sterilization evaluation and disinfection testing.

What you will be doing

• Perform disinfection and cleaning of reusable devices. Evaluating system designs for areas of risk for cleaning and disinfection, support experiments to evaluate the efficacy of the disinfection and providing recommendations for disinfectants and designing disinfection processes.
• Work with product development teams, product design owners, contract testing laboratories and manufacturing QA/QC laboratory personnel to complete required tasks.
• Support re-qualification for sterilization and microbiological test methods, internally and at manufacturing sites.
• Responsible for helping design and lead testing on biofilms. Designing biofilm experiments (including biofilm controls), operating the biofilm reactors, and evaluating biofilm samples.
• Responsible for helping to evaluate various sterilization cycles and write reports.
• Track and document micro lab employees' lab training and ensure compliance; work with other site team lead to further establish overall process and tracking.
• Responsible for organizing and documenting weekly/monthly lab testing schedule and assigning responsibilities to team.
• Responsibilities include:
  • Support Laboratory manager to maintain laboratory operations, including maintaining laboratory safety, improving operations and maintaining equipment.
  • Assure laboratory and documentation is audit ready and team can effectively response to auditor inquiries.
  • Assure appropriate investigations are conducted for laboratory failures and out of specifications.
  • Assure the use of appropriate standards in laboratory testing.
  • Supporting R&D projects through input on laboratory testing needs or the use of existing data to support products.
  • Devising new approaches to complex problems through adaptations and modifications of standard technical principles.
  • Where necessary implement new procedures to support the testing of Vantive products.
  • Assuring all work complies with Vantive's Quality system and cGDP/cGMP practices.
  • Providing regular updates to Sterility Assurance management.

What you will bring

• B.S. with greater than 8 years of related experience
• Strong Microbiology background and experience required in the areas of:
  • Biofilm testing including biofilm experimental design, growth methods, biofilm reactors and biofilm sampling techniques.
  • Performing disinfection testing including knowledge of disinfectants, regulatory knowledge and experimental design, to demonstrate the disinfection efficacy for demonstrating product safety for reusable medical devices.
  • Performing Bacterial Endotoxin Testing (BET) for new product development.
  • Performing Moist heat sterilization of test materials as well as pharmaceutical and medical device test samples.
• Experience managing multiple simultaneous projects and work activities
• Experience leading and coordinating laboratory activities and drawing conclusions from laboratory lab data.
• Knowledge of renal therapies (Hemodialysis and Peritoneal Dialysis)
• Knowledge of GDP/GMP/GLP practices.
• Ability to convince management on courses of action with minimal assistance using both written and verbal methods.
• Project Management certification preferred
• Medical device testing
• Experience in laboratory methods, including:
  • Bioburden
  • Sterility testing
  • Bacterial Endotoxin Test (BET)
  • Sterile barrier / Container Closure Integrity (CCI)
  • Antimicrobial testing
  • Moist heat sterilization efficacy support

Vantive is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a minimum of 3 days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission.

We understand compensation is an important factor as you consider the next step in your career. At Vantive, we are committed to…