Senior Sterilization Microbiologist

About the role

The Senior Sterilization Microbiologist plays a critical role in ensuring product safety and regulatory compliance through the development, validation, and oversight of sterilization processes. This position requires strong technical expertise, leadership, and cross-functional collaboration.

Responsibilities

• Lead sterilization validation activities (IQ/OQ/PQ, MPQ/PPQ) for new and existing products.
• Develop and review sterilization protocols, reports, and cycle parameters.
• Serve as SME for sterilization processes (EO, Gamma, E-beam, Steam).
• Ensure compliance with regulatory standards (FDA, ISO 11135, ISO 11137, ISO 17665).
• Support investigations related to bioburden, sterility failures, and deviations.
• Oversee bioburden, endotoxin, and environmental monitoring programs.
• Collaborate with cross-functional teams (Quality, Engineering, Operations, external suppliers like sterilization vendors).
• Review and approve changes impacting sterilization processes.
• Provide guidance during audits and regulatory inspections.
• Drive continuous improvement initiatives in sterilization and microbiology processes.

Requirements

• Minimum Requirements: Bachelor's degree and minimum of 4 years of relevant experience OR Master's degree with a minimum of 2 years relevant experience OR PhD with 0 years relevant experience.
• Nice to Have: Bachelor’s or Master’s degree in Microbiology, Biology, or related field; 5 to 10 years of experience in sterilization microbiology (medical devices/pharma preferred); Strong knowledge of sterilization validation and microbiological methods; Experience with regulatory submissions and audits; Experience with LIMS, SAP, MES, and BPCS required.

Skills

• Deep expertise in sterilization technologies and microbiology.
• Strong analytical and problem-solving skills.
• Leadership and project management capability.
• Excellent technical writing and communication skills.
• Ability to work cross-functionally and with external partners.

Benefits

Competitive Salary and flexible Benefits Package including:

• Health, Dental and vision insurance
• Health Savings Account
• Healthcare Flexible Spending Account
• Life insurance
• Long-term disability leave
• Dependent daycare spending account
• Tuition assistance/reimbursement
• Simple Steps (global well-being program)

Short-term incentive called the Medtronic Incentive Plan (MIP) is also available.