Johnson & Johnson Careers

Principle Process Microbiologist

Malvern, Pennsylvania
Operations (Generalist)


Job Description

Requisition ID: 9559180813

Janssen Biotech, Inc., a member of the Johnson & Johnson Family of Companies, is recruiting for a Principle Process Microbiologist located in Malvern, PA.

At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.  

Janssen Biotech, Inc. delivers on the promise of new treatments and ways to improve the health of individuals with serious disease. Built upon a legacy of innovative firsts, Janssen Biotech pursues advancing patient care with immunology and oncology solutions. Please visit www.JanssenBiotech.com for more information. We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.

Thriving on a diverse company culture, celebrating the uniqueness of our employees and committed to inclusion. Proud to be an equal opportunity employer.

As the Principle Process Microbiologist, you will:
• Lead the development and improvement of the contamination prevention programs, microbiological hygiene programs, as well as the investigation for those programs. 
• You will have co-responsibility for the establishment, control and implementation of the training curriculum concerning microbiological hygiene & contamination prevention. 
• Provide pragmatic advice to production operators, Team leaders and management on topics concerning contamination risk prevention. 
• As Investigation Lead for microbial contaminations, you will manage the multi-departmental / multifunctional investigation team and are responsible for reporting the investigation results and for identifying the preventative actions.
• Establish, document and escalate risks related to contamination of production processes and products; identify preventative actions related to contamination control that are a result of risk analysis, observations and deviations and ensure implementation by follow up & control. 
• Review changes to the facility, gowning, environmental control, process, process equipment, testing and microbial specifications.
• Drive improvements related to the reduction of contamination risks and the improvement of microbiological hygiene, and ensure improvements are executed and implemented. 
• Have a good understanding of the production processes and critical process steps in relation to contamination control; provide input to the aseptic techniques involved in these process steps and other areas related to contamination control such as Equipment/facility design, Cleaning & Disinfection, Gowning and transport of Man & Materials into and through the facility. 
• Establish, control and improve training and training curricula related to microbiological hygiene and contamination prevention. These trainings should be tailor made for each employee working in production areas; organize and give training on these subjects where required. 
• Perform risk analyses for projects & business innovation initiatives from a microbiological perspective; identify risks and opportunities in relation to contamination control on the shop floor and adequately drive follow up initiatives to for improvement in close cooperation with operators and management.
• Transfer knowledge and create understanding by communication to all levels in the organization and achieve goals through actively working with departments and individuals involved, building bridges and being customer focused while keeping a good focus on the business requirements.
• Lead investigations and coach Deviation Lead Investigators during contamination investigations or because of observations or when the hygiene monitoring program indicates a need; facilitate investigations or Kaizen events using appropriate techniques like Event Mapping and Kepner-Tregoe analysis.

Qualifications
• A minimum of a PhD in Biology, Biochemistry, Microbiology or related discipline is required.
• A minimum of three (3) years of related experience in a regulated industry is required.
• Thorough knowledge of current Good Manufacturing Practices (cGMP) and applicable industry regulations is required.  
• Experience on the shop floor in a pharmaceutical or biotechnological manufacturing environment is strongly preferred.  
• Experience with routine and non-routine environmental testing and sampling methods, techniques and related equipment is preferred.
• A strong background in statistical data analysis is preferred.
• Experience interacting with regulatory agencies is preferred.
• The ability to effectively don and wear required gowning materials (one-piece jumpsuits, head covers, gloves, surgical masks and the like) is required.  
• Ability to read, write and communicate in a technical environment is required.
• This position may require up to ten percent (10%) of domestic and international travel, depending on business demands.

Primary Location
United States-Pennsylvania-Malvern
Organization
Janssen Biotech, Inc. (6014)
Job Function
Operations (Generalist)
Requisition ID
9559180813