Staff Scientist Microbiology Quality & Sterility Assurance; MQSA), Orthopedics

At 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 Med Tech, 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.

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Quality

R&D/Scientific Quality

Professional

Raynham, Massachusetts, United States of America;
Warsaw, Indiana, United States of America

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.

Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes.

Johnson & Johnson is recruiting for a Staff Scientist Microbiological Quality & Sterility Assurance (MQSA), located in Raynham, MA or Warsaw, IN
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Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Your unique talents will help patients on their journey to wellness. Learn more at

• Subject matter expert expertise on R&D/Scientific Quality and assists in the review of policies that may impact organizational objectives.
• Lead the design of new manufacturing processes, controlled environments and packaging for microbiological quality, terminal sterilization and reprocessing.
• Assists in the oversight and monitoring of laboratory experiments to test the physical and/or chemical specifications of various substances, materials, and product.
• Design systems to collect and test samples and prepare detailed observations to ensure conformity to physical and/or chemical specifications.
• Implement processes to ensure the internal organization’s alignment with overall quality priorities.
• Help establish formal escalation processes to surface issues of product quality, regulatory compliance, and quality systems.
• Delivers research related to areas such as microbiology and sterility.
• Coaches more junior colleagues in technique, processes, and responsibilities.
• Understands and applies Johnson & Johnson’s Credo and Leadership Imperatives in day-to-day interactions with team.
• Lead J&J MQ&SA as a point of contact or a service leader within operating company supporting new and modified product/process/packaging development and optimization.

• Bachelors or equivalent university degree in Microbiology, Biology, Engineering or related discipline is required.

• A minimum of 4-6 years of related experience in a medical device and/or pharmaceutical industry in a GMP and/or ISO regulated environment.
• Experience managing a workplace in compliance with regulatory or company requirements.
• Ability to communicate science to line management on schedules and processing timetables to ensure timely completion.
• Demonstrate strong technical knowledge in microbiological testing and requirements: including cleaning validations, sterilization validations, routine microbiological and chemical contamination control requirements and reprocessing requirements for medical devices.
• Experience integrating new technologies and test methods into routine practice.
• Conducts technical assessments, evaluates suppliers'…