J&J Family of Companies Senior Staff Scientist, Industrial Microbiology in Raritan, New Jersey
The Johnson & Johnson Family of Companies, is recruiting for a Senior Staff Scientist, Industrial Microbiology to be located in Raritan, NJ.
Caring for the world, one person at a time, has inspired and united the people of Johnson & Johnson for 125 years. We embrace research and science -- bringing innovative ideas, products and services to advance the health and well-being of people. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world.
Technical leader and contributor in the area of industrial microbiology with responsibility to support all J&J locations worldwide with technical competency and resourcing gaps.
Supports compliance and risk-based evaluation and provides in-depth technical support for new and existing microbial controlled products including technology concepts, process development and validation activities.
External influencing- actively network with the internal and external scientific, technical and regulatory community to maintain state of the art knowledge.
Lead and facilitate new method development for industrial microbiology testing applications.
Provide talent development and training of microbiology analysts and other associates that use microbiology for validation of processes.
Provide microbiology support to regional and enterprise laboratory testing to independently interpret data and identify and correct issues.
Performs applied research and development initiatives, including integrating new technologies and test methods into routine practice.
Develops creative microbiology solutions for sterilization/aseptic processing of products not amenable to traditional methods.
Integrator for new acquisitions to Sterility Assurance including performing gap analyses and developing corrective action plans.
Develops internal technical standards / guidance and establishing associated training programs
Conducts technical assessments to qualify suppliers and other contract services (contract testing labs and BI suppliers).
Co-Leads Microbiology Analyst Training and Certification Program and implement training programs and initiatives to develop microbiological skills.
Develops and executes strategies for Sterility Assurance Labs.
Supports equipment qualifications to ensure accuracy and consistency of results.
Provides support and direction to affiliate operating companies on new microbiology methods, process optimization, and trouble-shooting out of specification (OOS) test results. Determine root cause and prescribes robust effective corrective action.
Initiates and investigates non-conforming laboratory test results and advances sterility assurance issues to management.
Leads in the development of internal technical documents.
Leads troubleshooting of microbially nonconforming manufacturing processes
Participates and leads in external organizations to influence industry development of standards and or position papers.
Provides support to ensure that Sterility Assurance services tactical objectives are aligned with strategic organizational targets.
Collaborates with internal regulatory compliance and external Regulatory Authorities during on-site inspections and related to submissions.
Bachelor’s degree (or equivalent) in a relevant scientific/technical field is required.
A minimum of 10 years of relevant experience (for example, lab testing, executing lab studies, developing and validating test methods to support Sterility Assurance) is required.
Solid understanding of key processes and activities within Sterility Assurance, and the interdependencies and interactions with other functions is preferred.
Understanding of practices, and/or scientific theories and principles regarding tests, studies, developments, and validation of test methods executed within Sterility Assurance is preferred.
Experience leading, and/or providing instruction to, professional and technical employees on projects and initiatives is required.
Experience leading the troubleshooting of process non-conformances, out of specification test results, and failure investigations, as well as providing resolution to issues via robust CAPA is required.
Experience conducting audits of in-house Microbiology Labs, contract/external labs, manufacturing processes, and critical utilities (i.e. water systems, compressed gases, controlled environments) is required.
Strong understanding of, and ability to interpret, applicable regulatory agency regulations and industry standards, and maintains currency on pharmacopeia compendia is required.
25% domestic and international travel is required as business demands.
United States-New Jersey-Raritan-
Johnson & Johnson International (6078)