Senior Microbiologist

Job Title:Senior Microbiologist
Job Location: Plymouth, MN/Remote
Job Duration: 10 Months
Job Description:
Top 3:

• 4+ years applied experience in radiation sterilization and ethylene oxide sterilization, specifically execution of validations.
• Environmental Monitoring (EM) subject matter expertise.
• Ability to multi-task, Skilled in planning, organizing, coordinating projects and working independently.
• Education/Experience Required: Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.
• 40 hours per week

Must Have:

• Specialized Knowledge or Skills Required: Thorough familiarity with FDA, EU and other international regulations, standards and guidelines covering sterilization and microbial contamination control in the manufacture of sterile medical devices.
• Solid understanding of different types of sterilization methods (EtO, gamma, steam, etc.) including processes and equipment.
• Proven leadership and knowledge in international and national standards such as AAMI/ANSI standards, E-Beam, ISO 17665 (Steam), 11137 (Radiation), 11135 (EtO) and others as applicable (i.e. EN).
• Specifically, Ethylene Oxide. Excellent organizational and judgment skills. Ability to maintain and generate accurate records. Strong written, verbal communication skills.

Nice to Have:
CISS Certification
Roles and responsibilities:
The Senior Microbiologist-Sterilization will be responsible for the sterility assurance EU-MDR remediation efforts by meeting the objectives detailed below:

• Objective # 1 - Locate Sterilization Validation Documentation:

The candidate will be given a list of product part numbers in Product for EU-MDR remediation. The candidate is expected to search within the multiple product life cycle management systems for each product part number on the EU-MDR list to locate validation documentation for sterile devices.
The candidate will create a list of all sterilization validation documents found for each product part number on the EU-MDR list.

• Objective # 2 - Review Sterilization Validation Documentation:

Once validation documentation has been located within product life cycle management system, review for compliance alignment to applicable International Standards (ISOs) and guidance documents.
For sterile disposable products, review sterilization validation documentation aProductst the requirements of applicable sterile method ISOs (ISO 11135, ISO 17665, ISO 11137, or ISO 14937)

• Objective # 3 Close identified compliance gaps:

For product part numbers with identified gaps
For sterile product part numbers with identified compliance gaps in terminal sterilization, lead efforts to remediate gaps by planning, executing, and managing sterilization validations at contract sterilizers and laboratories. Includes protocol and report writing.

• Objective # 4

Optimize EO sterilization validation for each product family to ensure gas concentration levels align with enterprise sterilization validation requirements: lead efforts by planning, executing, and managing sterilization validations at contract sterilizers and laboratories. Includes protocol and report writing.