Microbiology Quality Sterilization Assurance Scientist II - Danvers, MA

Johnson and Johnson is currently seeking a Microbiology Quality Sterilization Assurance Scientist II to join our team, located in Danvers, MA.

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 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/.

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world. Our diverse workforce and culture of belonging accelerate innovation to solve the world’s most pressing healthcare challenges. We know that the success of our business – and our ability to deliver meaningful solutions – depends on how well we understand and meet the diverse needs of the communities we serve. Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued and our people can reach their potential.

At Johnson & Johnson, we all belong.

Microbiology Quality Sterilization Assurance Scientist II is responsible for maintaining the Environmental, Microbiology and Sterilizations systems and practices through the implementation of the appropriate Medical Device standards. The candidate will be an individual contributor in these areas and coordinate all related activities across the organization.

Principle Duties and Responsibilities:

• Works with production to maintain control contamination practices.
• Facilitates the timely sampling of Bacterial Endotoxin and Bioburden samples.
• Works closely with engineering investigation teams to assure the timely closure of technical investigations.
• Works with R&D, manufacturing and quality to bring new product and changes to existing products to completion as the sterilization SME.
• Coordinates, monthly, quarterly and annual environmental monitoring testing.
• Works with sterilization vendors in order to resolve any non-conformances.
• Prepares metrics and trending reports for Sr. Management on a monthly basis.
• Support Non- Conformance and Corrective and Preventative Actions (CAPAs) investigations that relate to the Product microbiology, sterilization and environmental monitoring.
• Prepares risk assessments, protocols and reports as necessary for EM and Sterilization projects.
• Assists management on departmental projects as necessary.