QA Process Microbiologist

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

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Malvern, Pennsylvania, United States of America

Job Description:

Johnson & Johnson is recruiting for a Lead Process Microbiologist , located in Malvern, PA!

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 https://www.jnj.com/innovative-medicine

We are currently seeking a highly qualified individual to join our Quality team as a Lead Process Microbiologist at our Clinical and Commercial Large Molecule Drug Substance Manufacturing facility. In this key role, you will be responsible for leading the Process Microbiology team in the development and/or improvement and maintenance of the contamination prevention programs and microbiological hygiene programs. Acting as a microbiological SME and working with investigators on microbiological contamination issues in the facility and providing pragmatic advice to production operators, team leaders and management on topics concerning contamination risk prevention. If you are passionate about quality/microbiological positions in the pharmaceutical industry and possess the necessary skills and experience, we invite you to apply for this exciting opportunity as a Lead Process Microbiologist. Join our team and contribute to the development of life-saving therapies in a dynamic and rewarding environment!

Key Responsibilities:

• Supports improvements and preventative actions related to the reduction of contamination risks and the improvement of microbiological hygiene as a result of risk analysis, and ensures that these improvements are realized and implemented.
• Provides meaningful input on the aseptic techniques involved in process steps and other areas related to contamination control such as equipment/facility design, cleaning & disinfection, gowning and transport of man & materials into and throughout the facility.
• Participates in and supports technical investigations of products or processes
• Analyzes environmental monitoring, water system and utility data for trends.
• Reviews and/or approves technical documents, reports and procedures.
• Maintains a presence on the shop floor where he/she will work closely together with the operators and management of the Manufacturing, and Maintenance departments.
• Works closely with other key stakeholders including the QC Microbiology SME, QC personnel, Quality Assurance, Quality Systems, Compliance groups and Operations.
• Represents the QA department in meetings or cross-functional teams, as requested.
• Prepares for and provides microbiological expertise during regulatory inspections as required.
• Develops technical knowledge of site personnel in the area of microbiology
• Responsible for creating/improving training and training curricula related to microbiological hygiene and contamination prevention as needed.

Qualifications

Education:

• Minimum of a B.S. in Biology, Biochemistry, Microbiology, or a related discipline is required
• An MS or PhD in Biology, Biochemistry, Microbiology, or a related discipline is preferred

Experience and Skills:

Required:

• Minimum of 6 years of experience is required
• Requires thorough knowledge of applicable cGMP requirements.
• Must have a detailed understanding of Large Molecule production processes and critical process steps in relation to contamination control.
• Experience on the shop floor in a pharmaceutical or biotechnological manufacturing environment.
• Advanced knowledge and understanding of regulatory requirements, i