Sterilization Lead

Science; Alameda (CA); On-site; USD 100,000 - 200,000; Full time

Benefits offered by this job

Competitive salary and equity

Medical, dental, vision, and life insu

Flexible vacation and holidays

Healthy meals and snacks for non-remo

Parental, jury duty, bereavement, and留

Job summary

Science is a vertically integrated technology company focused on solving neuroscience’s hardest questions. In Alameda, you will build and own the in-house sterilization program, starting with EtO sterilization and microbiology testing capability.

You will validate loads, write plans, run equipment, and document each load as compliant. As the program matures, you will lead a team under the Head of Clinical Services and collaborate with QA and Regulatory Affairs to ensure compliant sterilization

Qualifications

• 5+ years in medical device sterilization.
• Experience with EtO validation and routine processing.
• Deep knowledge of ISO 11135, ISO 10993-7, and ISO 11138.
• Experience with ISO 13485 and 21 CFR Part 820 (QMSR).
• Experience with microbiology release testing.

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, and sterility testing and EO residuals through outside labs.
• Keep the sterilization program in a validated state as products and processes change, including assessing impact of design, material, supplier, and site changes, maintaining the validation master file.
• Train cleanroom operators and other staff on sample collection, equipment operation, and sterilization procedures.

Skills

Sterilization

EtO validation

Regulatory compliance

ISO 11135

Quality systems

Team leadership

Job description

Science is a vertically integrated technology company focused on solving some of neuroscience’s hardest questions and most serious unmet medical needs. We work to restore quality of life to those with debilitating conditions for which there are no treatment options, creating devices aimed at restoring vision, cognition, and mobility to patients who have lost them. To support progress across our industry, we provide state-of-the-art components and vertically integrated infrastructure for others to build on via Science Foundry.

As Sterilization Lead, you'll build and own Science's in-house sterilization program, starting with the build-out of an ethylene oxide (EtO) sterilization and microbiology testing capability at our Alameda facility. This is a rare chance to design and commission a sterilization operation from the ground up rather than manage an outsourced one. You'll be responsible for delivering fully validated sterile products to programs across the company, from small-batch lot release for early clinical studies to commercial-scale sterilization of Class III implants. This is a hands-on, onsite role: you'll write the validation plans, run the equipment, and maintain the documentation that shows each load was sterilized correctly. As the program matures, you'll work with the Head of Clinical Services to build a team underneath you and offer sterilization as a service to external partners. This role reports to the Head of Clinical Services and works closely with the Quality Assurance and Regulatory Affairs team.

Role 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.
• 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.

Preferred qualifications:

• Experience building a sterilization or microbiology capability from scratch, at a manufacturer or a contract sterilizer.
• Deep working knowledge of ISO 11607 and ISO 11737-1,2, and 3
• Experience setting up or running sterility testing under USP <71>, including cleanroom qualification and environmental monitoring. Experience with cleanroom environmental monitoring under ISO 14644.
• Experience coordinating sterilization and packaging across sites or with international partners.
• Experience with additional sterilization methods, such as radiation, vaporized hydrogen peroxide (VHP), or moist heat (autoclave).

Science is required under California law to include a reasonable estimate of the compensation range for this role. We determine your level based on your interview performance and make an offer based on the indicated salary band. The base salary range for this full-time position is $100,000-$200,000 annually + equity + benefits. Within the range, individual pay is determined by several factors, including job-related skills, experience, and relevant education or training. Please keep in mind that the equity portion of the offer is not included in these numbers.

At Science, our benefits are in place to support the whole you:

• 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)

Science Corporation is an equal opportunity employer. We strive to create a supportive and inclusive workplace where contributions are valued and celebrated, and our employees thrive by being themselves and are inspired to do their best work.

We seek applicants of all backgrounds and identities, across race, color, ethnicity, national origin or ancestry, citizenship, religion, sex, sexual orientation, gender identity or expression, veteran status, marital status, pregnancy or parental status, or disability. Applicants will not be discriminated against based on these or other protected categories or social identities. Science will also consider for employment qualified applicants with criminal histories in a manner consistent with applicable federal, state, and local laws.