Senior Scientist MQSA

Company: Disability Solutions
Location: Santa Rosa
Posted on: November 1, 2024

Job Description:

Johnson & Johnson is currently recruiting for a Senior Scientist of Microbiological Quality and Sterility Assurance (MQSA), supporting the Laminar business, located in Santa Rosa, CA. The position is eligible to participate in J&J Flex, working days both in the office and remote each week.\rThriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion, we are proud to be an equal opportunity employer.\rAt Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at https://www.jnj.com/.\rLaminar, recently acquired by Johnson & Johnson, is a clinical stage medical device company advancing transseptal left atrial appendage (LAA) closure. The LAA is a small pouch in the left atrium of the heart that is a major contributor to thromboembolic stroke in patients with atrial fibrillation. It has developmental, ultra-structural, and physiological characteristics distinct from the left atrium proper. Growing incidence of atrial fibrillation and medical device developments have rapidly expanded the market.\rIn this role, the Senior Scientist of Microbiological Quality and Sterility Assurance (MQSA) will support Laminar and Biosense Webster by performing complex (such as study lead for sterilization validation) and routine tests (such as environmental monitoring sampling of the clean rooms, water and air) in compliance with the laboratory test methods and procedures in order to provide support of New Product Development (NPD), Manufacturing, Regulatory, and other operational partners. The scientist will lead and support the sterility assurance and microbiology aspects of functional, project, and validation program deliverables to ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards as they pertain to medical devices. The scientist will also provide general guidance and mentorship to less senior team members to accomplish company and departmental objectives. The scientist will also be responsible and accountable for providing assurance that projects related to validation programs, new products, existing process modifications, and other technical projects related to microbiology and sterilization are completed according to regulation and procedure.\rKey Responsibilities:

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• As assigned, serve as a liaison between the Microbiological Quality & Sterility Assurance (MQSA) team and operations execution team during the development and selection of sterilization modalities, cycle development, and process validations.
• Work directly with the R&D teams to validated and transfer break-through technologies to enable future growth and innovations.
• Drive selection of sterilization modality, validation approaches and validation of the sterilization process for new products, and the sites for execution.
• Support microbiological aspects of the control and monitoring of the manufacturing environment, including controlled systems such as clean compressed air and purified water.
• Lead sterilization validations/revalidations studies or special projects as assigned.
• Communicates affairs related to the company or business opportunities to immediate supervisor and project teams, as applicable.
• Performs complex, routine tests in compliance with the laboratory procedures and tests methods to provide support to the timely delivery and product manufacturing to customers.
• Manage logistics of sterilization samples, review sterilization lot records (i.e., cycle run records, contract lab test reports, BI placement form), organize documents and submit (if applicable) for final release.
• As directed by the Staff Scientist of MQSA, take the lead in collaborating with other Department representatives (i.e., Calibration, De-contamination Lab, Packaging, Production, Engineering) for special studies or independently for routine functional issues.
• Leads in the performance and/or troubleshooting of test method and equipment validation and training.\r\r

Keywords: Disability Solutions, Fremont , Senior Scientist MQSA, Other , Santa Rosa, California