Senior Sterilization Microbiologist

POSITION SUMMARY:

The Senior Sterilization Microbiologist provides subject matter expertise in Sterilization Validation, OPS, Quality and Compliance related activities. Performs sterilization validations for new and existing products utilizing Ethylene Oxide and Radiation sterilization methods. Supports R&D, Regulatory Compliance, and manufacturing for sterilization validation of new products and changes to existing products.

POSITION RESPONSIBILITIES:

• Provides SME support and troubleshooting to sterilization nonconformances and technical challenges.
• Conduct microbiology testing including biological indicator incubation time studies.
• Uses knowledge of sterilization standards and regulations to provide RA submissions, audit support, and application to procedures.
• Write protocols and reports (sterilization, bioburden recovery, ETO dissipation, etc.).
• Determine new test methods as appropriate.
• Create laboratory operation procedures and follow guidelines from regulatory agencies.
• Establishes and cultivates an extensive network of support to facilitate the completion of assignments.
• Participates in the development of less experienced staff by setting an example, providing guidance and work direction, and offering counsel.
• May lead a project team.
• Participates in determining goals and objectives for projects.
• Influences middle management on technical or business solutions.
• Will interact with sterilization vendors.
• Plans and organizes non-routine tasks w/approval.
• Initiates or maintains work schedule.
• Establishes priorities of work assignments.
• Exercises judgment in selecting innovative, practical methods to achieve problem resolution.
• Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.

REQUIRED QUALIFICATIONS:

• Bachelor’s in a related field or an equivalent combination of education and work experience.
• 6 years minimum related work experience with a strong understanding of specified functional areas.
• Strong understanding in ethylene oxide (EO) and Radiation sterilization modalities