Senior Scientist of Microbiological Quality and Sterility Assurance

6010-Biosense Webster Legal Entity • Irvine, CA

1d • Onsite

About The Position

We are searching for the best talent for Senior Scientist of Microbiological Quality and Sterility Assurance to join our Biosense Webster Quality organization located in Irvine, CA. This is a 12-month fixed-term role. An internal pre-identified candidate for consideration has been identified. However, all applications will be considered. About Electrophysiology Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. As Johnson & Johnson MedTech Electrophysiology, we have one goal – to ensure those with atrial fibrillation can live the lives they want. For more than 30 years, we’ve been the global market leader in the science and technology of cardiac arrythmia treatment. Our suite of tools means electrophysiologists are empowered to personalize their approaches for patients with effective and reproducible workflows. Together, we’re changing what it means to be diagnosed with atrial fibrillation or other cardiac arrhythmias. Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech The Senior Scientist of Microbiological Quality and Sterility Assurance will support 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. Leads and supports 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. Provides general guidance and mentorship less senior team members to accomplish company and departmental objectives. Responsible and accountable for providing assurance that projects related to validation programs, new products, existing process modifications, and other technical projects in the microbiology laboratory areas are completed according to regulation and procedure.

Requirements

• BS Degree in biology, microbiology, biochemistry, engineering, or a related field of study is required
• A minimum of 4 years of experience with knowledge of medical device company operations, quality standards and GMP regulations of a medical device or pharmaceutical company
• Strong technical writing skills, the ability to manage multiple projects simultaneously and the ability to fluently change priorities based upon business need
• Experience with us of ethylene oxide and at least one additional sterilization modality (e.g. radiation, moist heat, dry heat)
• Qualified candidates will have experience in microbiology, sterilization validation (terminal, aseptic, and/or reprocessing) and environmental controls for a medical device or pharmaceutical manufacturing facility.
• Good interpersonal and organizational skills.
• Comfortable to work with multi-functional teams.
• Strong attention to detail.

Nice To Haves

• Master’s Degree in science
• Experience with GMP audits, internal and relevant external audits
• Experience with overseeing biocompatibility studies

Responsibilities

• As assigned, serve as a liaison between the microbiological quality & sterility assurance R&D team and operations execution team during the development and selection of sterilization modalities, cycle development and process validations.
• Work directly with the BWI 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 filtered 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.
• 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 Senior Manager of Microbiological Quality and Sterility Assurance, 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.

Benefits

• Vacation –120 hours per calendar year
• Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
• Holiday pay, including Floating Holidays –13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year
• Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
• Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
• Caregiver Leave – 80 hours in a 52-week rolling period
• 10 days Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year

What This Job Offers

• Job Type: Full-time
• Career Level: Senior