Microbiologist II, 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.

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

Description of Role:

• The role will have responsibility for helping design and lead testing on biofilms. Designing biofilm experiments (including biofilm controls), operating the biofilm reactors, and evaluating biofilm samples.
• The role will have responsibility for helping to evaluate moist heat sterilization cycles and write reports.
• The role will have responsibility for performing 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.
• This is a laboratory-based position with up to 5 days/week working in the laboratory. Some of the paperwork and non-laboratory-based activities can be conducted from home at the Lab Manager's discretion.
• May provide training and supervision to junior members within the disciplines. Routinely provide advice and assistance to team members regarding unique problems.
• 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.

Qualifications. The preferred candidate will have:

• Strong Microbiology background and experience required in the areas of:
• Biofilm testing including biofilm experimental design, growth methods, biofilm reactors and biofilm sampling techniques.
• Sterilization modalities and performing studies to demonstrate efficacy.
• 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 medical device and/or pharmaceutical industry
• 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.
• Effectively operates in cross-functional teams.
• Must be able to provide solutions that reflect understanding business objectives and cost implications.
• Ability to effectively mentor junior level associates
• Degree in Microbiology or related discipline.
  • B.S. with greater than 6 years of related experience.

Desired Skills

• 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
• Display a solid understanding of theories/practices utilized by other disciplines outside primary area of expertise.
• Experience participating in professional and/or standards organizations.

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 equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $80-110,000 annually. The estimated range is meant to reflect an anticipated salary range for the position. We may pay more or less than the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

US Benefits at Vantive

This is where your well-being matters. Vantive offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical, dental and vision coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance. Financial and retirement benefits include the Aon Pooled Employer Plan ("Aon PEP"), Vantive's 401(k) retirement savings plan, to help you prepare for your future. The Aon PEP is designed to help improve retirement outcomes by providing retirement resources more efficiently. The plan offers a robust set of investment options, financial education, and a suite of resources to support your retirement goals.

We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits. Join us and enjoy the competitive compensation and benefits we offer to our employees.For additional information regarding Vantive's US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Vantive

Equal Employment Opportunity

Vantive is an equal opportunity employer. Vantive evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

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Reasonable Accommodation

Vantive is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information. Form Link

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