Senior Sterilization Scientist

Johnson & Johnson•San Angelo, TX

About The Position

Johnson & Johnson MedTech is recruiting a Senior Sterilization Scientist in San Angelo, Texas, to conduct research and development work in the Ethylene Oxide (EO) sterilization area. Under minimal supervision, the role uses established and novel technology to support complex projects and provide technical expertise to Ethicon Manufacturing. The scientist is responsible for EO sterilization execution and maintenance activities and serves as the first point of contact for technical inquiries. The position oversees daily sterilization operations, supports and qualifies sterilization processes, validates new processes and products, evaluates change controls, and conducts EO cycle, NPRT, and product residual re-qualifications or analyses. The role also contributes sterilization expertise to multidisciplinary teams working on surgical sutures, biosurgical applications, and medical devices. It investigates non-conformances and product inquiries, supports related CAPAs, tracks and trends data, and implements process improvements. The scientist plans and directs engineering projects and studies, applies broad scientific and technical knowledge, and exercises independent judgment in selecting methods and evaluation criteria. The role may coordinate technical support staff and provide guidance to lower-level scientists or engineers. It also serves as backup signature authority for the Base Business Sterilization team and must comply with applicable quality, environmental, health, safety, regulatory, and company requirements. English fluency is required, and travel may be up to 10%.

Requirements

Bachelor’s degree or higher in Science, Engineering, Biomedical Science, or an equivalent related field.
Two to four years of relevant work experience.
Experience within the medical device industry.
Broad understanding of environmental control, packaging, and manufacturing process impacts on sterility assurance.
Thorough experience with sterilization processes and knowledge of the Ethylene Oxide process.
Demonstrated experience with change control in 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.
Leadership skills in project management and technical expertise.
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 as part of a team.
Mastery of analytical skills and professional judgment needed to resolve major technical issues.
Ability to make management-level presentations, write formal reports addressing technical and business implications, and prepare project plans while understanding interrelationships.
English fluency.

Nice To Haves

Experience with LIMS or ERP.
Analytical reasoning, computerized equipment skills, familiarity with emerging technologies, Gemba Kaizen, issue escalation, lean supply chain management, problem solving, process control, process engineering, process-oriented work, product improvements, STEM application, situational awareness, supply planning, technical research, technological savvy, or validation testing.

Responsibilities

Manage EO sterilization execution and maintenance activities and serve as the first point of contact for technical inquiries from Ethicon Manufacturing.
Plan, conduct, and direct engineering projects and studies requiring advanced sterilization knowledge.
Oversee daily sterilization operations, including review of deviations and corrections and assessment of trends.
Provide technical support for the sterilization process.
Execute periodic sterilization process qualifications and performance metrics.
Validate new processes and products, including product qualification (PQ), and establish success criteria.
Assess the impact of product and process change controls related to sterilization.
Conduct EO cycle and NPRT re-qualifications.
Perform periodic product EO residual analysis.
Provide sterilization expertise on project teams to build internal knowledge and support business decision-making.
Investigate failures and assess product impact for non-conformances related to sterilization parameters.
Provide technical support for CAPAs related to sterilization issues.
Contribute to multidisciplinary project teams designing, developing, and manufacturing surgical sutures, biosurgical applications, and medical devices.
Track and trend data and identify and implement process improvements to improve business measures.
Investigate product inquiries and develop and implement appropriate corrective actions.
Analyze data and complex situations and select methods, techniques, and evaluation criteria to resolve technical issues.
Coordinate and direct technical support staff as needed and support the technical development of assigned staff.
Provide guidance and work direction to lower-level scientists and engineers as needed.
Serve as backup signature authority for the Base Business Sterilization team.
Communicate business-related issues or opportunities to the next management level.
Follow applicable quality management, environmental, safety, occupational health, regulatory, and company policies and procedures; ensure subordinate compliance and resource readiness where applicable.
Perform other duties as assigned.