Apply on Employer Site

Vantive · 1 hour ago

Microbiologist III, Sterility Assurance

St Paul, MN

Full-time

Hybrid

Senior Level, Lead/Staff

$96K/yr - $144K/yr

8+ years exp

Vantive is a vital organ therapy company focused on extending lives and improving patient care through innovative solutions. The Microbiologist III will oversee laboratory testing, including microbiological testing and sterilization evaluations, while collaborating with product development teams and ensuring compliance with quality standards.

Health CareMedicalTherapeuticsWellness

Responsibilities

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

Qualification

MicrobiologyBiofilm testingDisinfection testingBacterial Endotoxin TestingMoist heat sterilizationProject Management certificationMedical device testingGDP/GMP/GLP practicesRenal therapies knowledgeLaboratory methods

Required

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

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