Process Microbiologist

Location: Malvern

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. Learn

more at  () .

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

** Job Function:*
* Quality

** Job Sub*
* ** Function:*
* Quality Assurance

** Job Category:*
* Professional

** All Job Posting Locations:*
* Malvern, Pennsylvania, United States of America, Spring House, Pennsylvania, United States of America

*
* Job Description:

*
* Johnson and Johnson Innovative Medicine, is recruiting for a Process Microbiologist! This position will be located in Malvern, PA and support the Spring House, PA site.

** About Innovative Medicine*
* Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at

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!

Learn more at

This role supports a variety of GMP activities including large molecule drug substance, cell banking operations, and CAR-T manufacturing. You will serve as the site microbiology subject matter expert. You will act as a liaison with other internal quality organizations to standardize policies, practices and procedures to increase quality and compliance and champion increased awareness of quality related concerns.

** Main responsibilities will include, but are not limited to:*
* + Serve as the site microbiology subject matter expert for GMP manufacturing, laboratory, and facility operations, providing technical guidance on microbiological controls, contamination prevention, and inspection readiness.

+ Support environmental monitoring, utility monitoring, bioburden, endotoxin, microbial identification, sterility assurance, and related microbiological programs to ensure product quality and patient safety.

+ Own and maintain site contamination control strategies. Lead monthly contamination control program reviews.

+ Review, trend, and interpret microbiological data to identify adverse trends, excursions, and potential contamination risks; partner with cross-functional teams to define appropriate actions.

+ Support investigations related to microbiological deviations, environmental monitoring excursions, contamination events, aseptic processing observations, and laboratory atypical results.

+ Provide microbiology input for change controls, risk assessments, protocols, validation activities, cleaning and sanitization strategies, and facility or process changes.

+ Author, review, and approve microbiology-related procedures, technical reports, protocols, specifications, and controlled documents in accordance with cGMP expectations.

+ Partner with Quality, Manufacturing, Engineering, Technical Operations, Validation, and Laboratory teams to maintain robust microbial control strategies across the site.

+ Support regulatory inspections, internal audits, and customer audits by preparing microbiology…