Staff Scientist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: Supply Chain Engineering Job Sub Function: Process Engineering Job Category: Scientific/Technology All Job Posting Locations: San Angelo, Texas, United States of America Job Description: We are searching for the best talent for a Staff Scientist in San Angelo, Texas! About MedTech: Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, and more personalized treatments. Your outstanding talents will help patients on their journey to wellness. Learn more at Johnson & Johnson MedTech (https://www.jnj.com/medtech). The Senior Scientist will conduct research directed toward discovery and/or development on a large research and development project or a number of small projects with many complex features under minimal supervision using established and novel technology. This role is responsible for providing sterilization expertise, technical support, validation support, process improvement leadership, and project execution within a regulated medical device manufacturing environment. Adheres to Environmental Health and Safety policies and procedures and supports department objectives. KEY RESPONSIBILITIES: Be responsible for EO sterilization execution maintenance activities and serve as the first point of contact for technical inquiries from Ethicon Manufacturing. Plan, conduct, and direct engineering projects or studies, including complete projects requiring advanced knowledge of sterilization. Oversee daily sterilization operations, including review of deviations and corrections, trend assessments, and technical support for the sterilization process. Execute periodic qualifications and performance metrics for the sterilization process. Conduct validation of new processes and products, including performance qualification (PQ) and establishment of success criteria. Assess the impact of product and process change controls for sterilization. Conduct EO cycle and NPRT re-qualifications. Perform periodic product EO residual analysis. Participate on project teams by providing sterilization expertise to build internal knowledge and support business decision-making. Perform failure investigations and product impact assessments for non-conformances related to sterilization parameters. Lead or provide technical support for CAPAs related to sterilization issues. Serve as a contributing member of multidisciplinary project teams in the design, development, and manufacturing of surgical sutures, biosurgical applications, and medical devices. Apply comprehensive and diverse knowledge of scientific principles and practices within broad assignment areas. May coordinate and direct activities of technical support staff and support technical development of assigned staff. Track and trend data, identify opportunities, and implement process improvements to improve business measures. Investigate product inquiries and develop and implement appropriate corrective actions. Analyze data and complex situations involving evaluation of tangible and identifiable variables to arrive at creative and effective solutions. Exercise independent judgment in selecting methods, techniques, and evaluation criteria for obtaining results on new assignments. May provide guidance and work direction to lower-level scientists and engineers. Serve as back-up signature authority for the Base Business Sterilization team. Comply with all applicable quality management system, environmental, safety, and occupational health policies, including ISO 11135, ISO 13485, ISO 14001, and OSHAS 18001. Communicate business-related issues or opportunities to the next management level. Follow all Company guidelines related to Health, Safety, and Environmental practices as applicable. Ensure personal and Company compliance with all Federal, State, local, and Company regulations, policies, and procedures. Perform other duties as assigned. QUALIFICATIONS Education: A minimum of a Bachelor’s degree in Science, Engineering, Biomedical, or an equivalent related field is required. EXPERIENCE AND SKILLS: Required: 4 years of relevant work experience is required. Experience within the medical device industry is required. Broad understanding of environmental control, packaging, and manufacturing process impact on sterility assurance. Thorough experience with sterilization processes, including Ethylene Oxide process knowledge. Proven experience in change control processes within a regulated industry, including development, implementation, and test method validation. Knowledge of ISO, FDA, and other regulated standards. Advanced computer skills, including Microsoft Office and software applications. Working knowledge of CAPA and non-conformance systems is required. Proficiency in project management leadership and technical expertise. Strong leadership skills, teamwork, initiative, creativity, assertiveness, attention to detail, and effective interpersonal skills. Ability to work in a team-oriented environment that embraces change, risk, and flexibility. Demonstrated ability to work independently and within