Sterilization Lead
Alameda, CA$100k - $200kfull-timePosted 2w ago
About the role
Lead the development and operation of Science's in-house sterilization program, beginning with EtO sterilization and microbiology testing at the Alameda facility. Responsible for delivering fully validated sterile products across programs, building a team over time, and offering sterilization services to external partners. Reports to the Head of Clinical Services and collaborates with QA and Regulatory Affairs.
Responsibilities
- Own Science’s sterilization program, including the documentation, regulatory compliance, and day-to-day operation of every load.
- Own equipment selection and qualification of chamber, aeration, and abatement systems.
- Write and execute sterilization validation plans under ISO 11135, including single lot release and parametric release studies, biological indicator and process challenge device strategy, and product family adoption.
- Own sterile barrier packaging validation under ISO 11607, including seal validation, in coordination with packaging partners and the production team.
- Run the testing program for sterilized product and other controlled materials, including bioburden, endotoxin, and mycoplasma in house (ISO 11737-1 and -3, USP <61>, USP <85>, USP <63>), and sterility testing (USP <71>) and EO residuals (ISO 10993-7) through outside labs held to defined turnaround times.
- Keep the sterilization program in a validated state as products and processes change, including assessing the impact of design, material, supplier, and site changes, maintaining the validation master file and procedures, supporting regulatory change notifications and audits.
- Train cleanroom operators and other staff on sample collection, equipment operation, and sterilization procedures.
Qualifications
- 5+ years in medical device sterilization, with hands-on responsibility for EtO validation and routine processing (particularly for an implantable or Class III device).
- Deep working knowledge of sterilization standards, e.g. ISO 11135, ISO 10993-7, and ISO 11138.
- Experience operating within an ISO 13485 and 21 CFR Part 820 (QMSR) quality system, including writing SOPs, protocols, and reports that hold up under audit.
- Experience running or overseeing microbiology release testing, including bioburden and endotoxin, and managing outside test labs.
- Comfort running equipment yourself, as well as owning the program.
- Sound judgment about sterility risk, including when to move fast and when not to.
- Ability to cover off-hour cycles and aeration activities.
Skills
Required:Sterilization program managementISO 11135ISO 10993-7ISO 11607QMS/RegulatoryBioburden/Endotoxin testingSterility testing (USP <71>)Ethylene oxide (EtO) sterilizationEquipment qualification
Benefits
- Competitive salary and equity
- Medical, dental, vision, and life insurance
- Flexible vacation and company-paid holidays
- Healthy meals and snacks provided for non-remote employees
- Paid parental, jury duty, bereavement, family care, and medical leave
- Dependent Care Flexible Spending Account, subsidized by Science
- Flexible Spending Account
- 401(k)
Last updated Oct 23, 2026. Interested? Apply on the company site.
About Science Corporation
Transcend the limits of biology
Science Corporation is a clinical-stage medical technology company.
medical technologybrain-computer interfaceneural interfacesvision restorationneurotechnology
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