Sterilization Microbiologist

Job Title: Sterilization Microbiologist
Location: Plymouth, MN (onsite)
Contract Duration: Contract until 12/31/2025
Work Hours: 8:30am - 5pm

Description:
This position is for the microbiologist that consistently applies microbiological concepts to the manufacturing process of a medical device and understands and develops process monitoring/metrics to maintain microbiological quality of the final device.

• Facility and Routine Production Microbiological Support: Develop and execute controlled access environment qualifications, specifications, and environmental disturbance reports.
• Provide guidance on controlled access environment gowning requirements. Develop and execute water system qualifications, compressed air systems, and specifications. Provide guidance on cleaning processes and chemical usage.
• Technical support for facility issues in the areas of environmental monitoring and microbiological methods.
• Assess manufacturing process changes for microbial impact.
• Technical Sterilization and Microbiological Laboratory Methods Support: Develop sterilization parameters based on device / packaging design. Troubleshoot routine and validation sterilization cycle nonconformances.
• Perform annual sterilization validations for ethylene oxide and steam cycles per regulatory requirements. Perform product sterilization adoptions.
• Knowledge and ability to perform mathematical sterilization calculations (i.e. lethality, D-value, etc.).
• Complete sterilization assessments for production changes (i.e. process changes, packaging changes, load configuration changes, design changes, etc.).
• Knowledge of reusable device regulatory requirements. Develop and validate microbiological test methods.
• Train laboratory technicians to microbiological test methods and equipment. Review routine microbiological test reports.
• Proactively identifies and shares opportunities, concerns, and solutions with cross functional partners. Mentor microbiology technicians/microbiologists and provide technical expertise. Conduct calibration out of tolerance investigations.
• Documentation and Technical Writing: Maintains understanding of applicable standards and applies them to qualifications and test methods.
• Writes protocol and reports for qualification of the following: Controlled access environments, compressed air systems, and water systems, Microbiological test methods, Sterilization validations / product adoptions, Equipment qualifications, LAL Sampling Analysis.
• Writes the following technical documentation: Laboratory procedures, Procedures for routine product monitoring and incoming component specifications,
• Quality Assurance Support: Review and release routine product sterile loads. Review and support supplier change notifications. Develop and review FMEAs.
• Review and approve nonconforming material reports. Act as a subject matter expert for supplier audits and internal/external audits.
• Other Requirements: Other Projects as Directed by Department Manager. Member of R&D project teams, Operations project teams, or supports other projects as directed by department manager
• Member of R&D project teams, Operations project teams, or supports other projects as directed by department manager.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Support all Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
• Complies with U.S. Food and Drug Administration (FDA) regulations, other regulatory requirements, Company policies, operating procedures, processes, and task assignments. Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.

Qualifications:
Bachelors degree with 5+ years of experience with Medical device/pharmaceutical, or related industry with work experience in microbiology and/or sterilization and relevant microbiology lab experience.

Experience Details
Articulates technical concepts well. Person in this position has demonstrated troubleshooting skills in complex situations outside of routine out of specification issues, such as sterilization or contamination issues while at the Microbiologist II level or equivalent.

• Experience working in a broader enterprise/cross-division business unit model preferred.
• Ability to work in a highly matrixed and geographically diverse business environment.
• Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
• Ability to leverage and/or engage others to accomplish projects.
• Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
• Multitasks, prioritizes and meets deadlines in timely manner.
• Strong organizational and follow-up skills, as well as attention to detail.
• Person in this position demonstrates professional skills with excellent written communication.
• Able to work with minimal supervision and ability to maintain regular and predictable attendance.
• Ability to travel approximately 5-25%, including internationally.