Medtronic logo
Medtronic

Engineering the extraordinary

Senior Sterilization Microbiologist

PrincipalGeneralFull TimeRemoteSeniorTeam 10,001+Since 1949H1B SponsorCompany SiteLinkedIn

Location

United States

Posted

3 days ago

Salary

$98.4K - $147.6K / year

Seniority

Senior

No structured requirement data.

Job Description

Senior Sterilization Microbiologist

Medtronic

Role Description The Senior Sterilization Microbiologist is responsible for leading the development, validation, and ongoing control of sterilization processes (e.g., EO, steam, radiation) to ensure product safety, regulatory compliance, and process robustness. This role provides technical expertise and strategic direction for microbiological aspects of sterilization across manufacturing and quality systems. This position is remote to enhance our competitive edge and expand our cross-functional collaboration efforts. This role will require 10% of travel to enhance collaboration and ensure successful completion of projects. Key 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. Qualifications - Requires a 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. - Requires a Bachelor’s or Master’s degree in Microbiology, Biology, or related field. - Requires 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. - For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required. Benefits - Competitive Salary and flexible Benefits Package. - 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. - Incentive plans, 401(k) plan plus employer contribution and match. - Short-term disability. - Paid time off. - Paid holidays. - Employee Stock Purchase Plan. - Employee Assistance Program. - Non-qualified Retirement Plan Supplement (subject to IRS earning minimums). - Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums).

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