- Entry level
- No Education
- Salary to negotiate
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.
About the company
If you’re thinking about taking your career to a place where you can be seen for the talent you bring to your work, where you’ll have a chance to be the driver of your own career, and where others share your passion for caring and success, then we invite you to explore Johnson & Johnson. BE VITAL in your career and make a unique mark. Join the approximately 129,000 men and women who work within our companies and touch the lives of more than a billion people around the world every day.