Johnson & Johnson Careers
Staff Scientist, Industrial Microbiology
Requisition ID: 3778181008
The Johnson & Johnson Family of Companies, is recruiting for a 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.
- Serve as a technical 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 provide 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 develop 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.
- Supports applied research and development initiatives, including integrating new technologies and test methods into routine practice.
- Develops innovative microbiology ideas for sterilization/aseptic processing of products not amenable to traditional methods.
- Assists in integration efforts for new acquisitions to Sterility Assurance including performing gap analyses and developing corrective action plans.
- Assists in the development of 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.
- Assists in the development of 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. Determines root cause and prescribes robust effective corrective action.
- Initiates and investigates non-conforming laboratory test results and escalates sterility assurance issues to management.
- Leads and/or participates in the development of internal technical documents.
- Assists in troubleshooting microbially nonconforming manufacturing processes
- Participates in external organizations to lead industry development of standards and or position papers.
- Provides support to ensure that Sterility Assurance services tactical objectives are aligned with strategic organizational targets.
- Interfaces 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 6 years of relevant experience (for example, lab testing, executing lab studies, developing and validating test methods to support Sterility Assurance) is required.
- 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.
- Strong understanding of, and ability to interpret, applicable regulatory agency regulations and industry standards, and maintains currency on pharmacopeia compendia 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 conducting audits of in-house Microbiology Labs, contract/external labs, manufacturing processes, and critical utilities (i.e. water systems, compressed gases, controlled environments) is preferred.
- 25% domestic and international travel is required as business demands.
United States-New Jersey-Raritan-
Johnson & Johnson International (6078)