Staff Scientific

For more than 130 years, diversity, equity & inclusion (DEI) has been a part of our cultural fabric at Johnson & Johnson and woven into how we do business every day.Rooted in Our Credo, the values of DEI fuel our pursuit to create a healthier, more equitable world.Our diverse workforce and culture of belonging accelerate innovation to solve the world's most pressing healthcare challenges.We know that the success of our business - and our ability to deliver meaningful solutions - depends on how well we understand and meet the diverse needs of the communities we serve.Which is why we foster a culture of inclusion and belonging where all perspectives, abilities and experiences are valued, and our people can reach their potential.At Johnson & Johnson, we all belong.We are searching for the best talent for Staff Scientific to be in Juarez, SalvarcarPurpose:Provide oversight and leadership for complex (such as study lead for sterilization validation and biocompatibility programs) and routine tests (such as environmental monitoring sampling of the clean rooms, bioburden, and bacterial endotoxin) in compliance with the laboratory test methods and procedures in order to provide support of New Product Development (NPD), Manufacturing, Regulatory and other operational partners.Leads and supports sterility assurance, biocompatibility, and microbiology aspects of functional, project, and validation program deliverables to ensure compliance with the company's Quality System policies and procedures and applicable external requirements and standards, including FDA, ISO *****, CMDCAS, PMDA and other worldwide regulatory agencies, Johnson & Johnson Environmental, Health & Safety Practices, and other applicable standards as pertains to medical devices.Provides general guidance and mentorship over Scientist I, II and III to accomplish company and departmental objectives.Provide leadership and oversight to direct reports as assigned.Responsible and accountable for providing assurance that projects related to validation programs, new products, existing process modifications, and other technical projects in the microbiology laboratory areas are completed according to regulation and procedure.You will be responsible for:Under (e.g., limited supervision, general direction, etc.) and in accordance with all applicable federal, state, and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:- As assigned, serve as a liaison between the microbiological quality & sterility assurance R&D team and operations execution team during the development and selection of sterilization modalities, cycle development and process validations.- Work directly with the BWI R&D teams to validated and transfer break-through technologies to enable future growth and innovations.- As assigned, advise in the selection of the aseptic processing and/or sterilization process for new products, and the sites for execution.- Support microbiological aspects of the control and monitoring of the manufacturing environment.- Provide oversight of complex, routine tests in compliance with the laboratory procedures and tests methods to provide support to the timely delivery and product manufacturing to customers.- Works in compliance with the current good manufacturing practices (GMPs) and good documentation practices (GDP) in regards of documentation, tests and maintenance, notebooks, and data sheets, in a precise manner.- Investigation execution of non-conformant laboratory tests results.- Collects and prepares sterilization validation and laboratory records for evaluation, following good documentation practices.- Communicates affairs related to the company or business opportunities to immediate supervisor and project teams, as applicable.- Performs in a competent manner, after training, routine tests by following the laboratory procedures and test methods.- Develops a competence after training of the use of laboratory instruments and equipment.- Ensures the compliance with the Local, State, and Federal and company regulations, policies, and procedures in compliance with Environmental, Health, and Safety (EHS).- Performs other tasks related to the laboratory that are assigned by management.- Provides support to internal, environmental and safety laboratory management.- Responsible for communicating business related issues or opportunities to next management level- Follow all Company guidelines related to Environmental, Health, and Safety (EHS) practices and communicate to manager when resources needed to do so are not available or not in good condition- Organize and present all testing performed (if applicable) within the microbiology lab to the Senior Manager of Microbiological Quality and Sterility Assurance for review.- Review sterilization lot records (i.e., cycle run records, contract lab test reports, BI placement form), organize documents and perform final review.- Authorize the Micr