Senior Scientist Of Microbiological Quality And Sterility Assurance

Biosense Webster Inc., a member of the Johnson & Johnson family of companies is currently recruiting for a Senior Scientist of Microbiological Quality and Sterility Assurance ! This position will be located in Irvine, CA.

Atrial fibrillation (AFIB) is a quivering or irregular heartbeat (arrhythmia) that can lead to blood clots, stroke, heart failure and other heart-related complications. 20 million people around the world suffer from AFIB each year. Biosense Webster, Inc. is the global leader in the science of diagnosing and treating heart rhythm disorders. The company established its leadership in electrophysiology with the development of the first real-time, 3D cardiac mapping and navigation technology, as well as the first electrophysiology catheter. The introduction of the company’s CARTO® 3 System in 2009 revolutionized 3D mapping technology by increasing the accuracy, speed, and efficiency of the cardiac ablation procedure.

The Senior Scientist of Microbiological Quality and Sterility Assurance will support NuVera Medical 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. 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.

Key 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.

Qualifications

Education:

A minimum of a Bachelors or equivalent University Degree is required, with a focused degree in biology, biochemistry, chemistry, engineering, or a related field of study preferred. Masters or Advance degree preferred.

Experience and Skills:

Required:

• Good interpersonal and organizational skills.
• 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
• Comfortable to work with multi-functional teams.
• Strong attention to detail.
• 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.
• Strong technical writing skills, the ability to manage multiple projects simultaneously and the ability to fluently change priorities based upon business need

Preferred:

• Experience with GMP audits, internal and relevant external audits
• Experience with overseeing biocompatibility studies

Other:

• This position may require up to 15% domestic travel.

This position has an estimated annual salary of 84,000- 152,000 USD.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.