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We are searching for the best talent for Staff Scientific to be in Juarez, Salvarcar
Purpose:
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 13485, 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.
• Provide subject matter expert support to life cycle management and network projects as assigned.
• 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 Microbiology release of NPD sterile finished devices for final inspection disposition based on review and approval of pertinent test results.
• Review and sign off on pertinent Microbiology records.
• As directed by Senior Manager of Microbiological Quality and Sterility Assurance, take the lead in collaborating with other Department representatives (i.e., Calibration, Decontamination Lab, Packaging, Production, Engineering) for special studies or independently for routine functional issues.
• Prepare and ship product or test samples to contract testing labs as required.
• Stays vigilant on the status of lab materials and supplies in the microbiological laboratory. Additionally, notify Senior Manager of Microbiological Quality and Sterility Assurance of faulty or damaged testing equipment. Interacts directly with vendors of supplies and equipment.
• Leads in the performance and/or troubleshooting of test method and equipment validation and training.
• Leads the training of Microbiology Technicians, Inspectors, and other Quality personnel conducting microbiology work.
• Coordinate training and testing schedule for supporting associates.
• Leads and provides guidance over the activities of the microbiology lab technician(s) and any other personnel working within the microbiology lab or performing microbiology work.
• Assigns, monitors, and reviews progress and accuracy of work of more junior employees keeping the Senior Manager of Microbiological Quality and Sterility Assurance appraised on status.
• Conduct internal Quality audits as directed by the Senior Manager of Microbiological Quality and Sterility Assurance.
• Lead sterilization validations/revalidations, biocompatibility studies or special projects as assigned.
• Generate NCs, perform investigation of NCs and NC action tasks, as assigned.
• Review trending reports for the data gathered from testing of clean rooms, water systems, compressed air and any other microbiological testing.
• Provide input to the Senior Manager of Microbiological Quality and Sterility Assurance for process improvement ideas related to the testing of clean rooms, support systems and product.
• Performs other duties assigned as needed.

QUALIFICATIONS

• BS Degree in a biological science, biochemistry, chemistry, physical science, or a related field of study is required; 6 or more years of experience with knowledge of company operations, quality standards and GMP regulations of a medical device or pharmaceutical company.
• Master’s degree in science is preferable with 5 or more years of experience with Master of Science.
• Progressively performing advanced tasks at Senior Scientist level
• Experience required in maintaining laboratory ordering and inventory.
• Required experience in the Medical Device industry.
• Required experience in conducting endotoxin testing (LAL) and investigations.
• Required experience in conducting environmental monitoring testing of controlled environments.
• Experience in conducting media Growth Promotion testing.
• Possess broad understanding of the English language and show the ability for oral and written communication in that language.
• Experience in writing protocols and reports to document execution of Biological Evaluation studies (Biocompatibility, Toxicology and Chemical Characterization) at contract laboratories.
• Demonstrated knowledge of manufacturing principles and practices, and procedures.
• Knowledge of specific business practices and software and software applications.
• High level knowledge of standards including EU MDR and ISO is required.
• Able to enter data on spread sheet and database applications.
• Ability to communicate effectively with a diverse supplier/vendor base.
• Ability to work cooperatively with coworkers and external suppliers and partners.
• Good interpersonal and organizational skills.
• Self-motivated.
• Deep knowledge of research fundamentals.
• Able to work overtime or weekend work (as needed).
• Ability to work in a special environment such as a clean room.
• Ability to wear protective garb such as lab or clean room gowns

Please refer the Job description for details