Senior Sterilization Scientist

Johnson & Johnson Innovative Medicine • San Angelo, TX

5d • Onsite

About The Position

Johnson & Johnson MedTech is recruiting a Senior Sterilization Scientist for its San Angelo, Texas location. The role conducts research and engineering work on complex projects in the Ethylene Oxide (EO) sterilization area, using established and novel technology with minimal supervision. The scientist is responsible for EO sterilization execution and maintenance and serves as the first point of contact for technical inquiries from Ethicon Manufacturing.

The position provides technical oversight and support for sterilization operations, qualifications, validations, requalifications, residual analysis, change control, investigations, and process improvements. It contributes sterilization expertise to multidisciplinary teams developing and manufacturing surgical sutures, biosurgical applications, and medical devices. The role may coordinate technical support staff and provide guidance to lower-level scientists and engineers, and serves as backup signature authority for the Base Business Sterilization team.

The role requires compliance with applicable quality management, environmental, safety, occupational health, and regulatory requirements, including relevant company guidelines and procedures. English fluency is required; travel of 10% is possible.

Requirements

• Bachelor’s degree in Science, Engineering, Biomedical, or an equivalent related field.
• 2–4 years of relevant work experience.
• Experience in 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.
• 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 experience using software applications.
• Working knowledge of CAPA and nonconformance systems.
• Leadership proficiency in project management and technical expertise.
• Leadership, 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 deliver 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.
• Listed preferred skills: Analytical Reasoning, Computerized Equipment Skills, Emerging Technologies, Gemba Kaizen, Issue Escalation, Lean Supply Chain Management, Problem Solving, Process Control, Process Engineering, Process Oriented, Product Improvements, STEM Application, Situational Awareness, Supply Planning, Technical Research, Technologically Savvy, and Validation Testing.

Responsibilities

• Maintain and execute EO sterilization activities and serve as the first point of contact for technical inquiries from Ethicon Manufacturing.
• Plan, conduct, and direct engineering projects or studies requiring advanced sterilization knowledge.
• Oversee daily sterilization operations, including reviewing deviations and corrections and assessing trends; provide technical support for sterilization processes.
• Execute periodic sterilization qualifications and assess performance metrics.
• Validate new processes and products, including performance qualification (PQ), and establish success criteria.
• Assess the sterilization impact of product and process change controls.
• Conduct EO cycle and NPRT requalifications.
• Perform periodic product EO residual analysis.
• Contribute sterilization expertise to project teams to build internal knowledge and support business decisions.
• Perform failure investigations and product impact assessments for sterilization-related nonconformances, and provide technical support for related CAPAs.
• Contribute to multidisciplinary teams designing, developing, and manufacturing surgical sutures, biosurgical applications, and medical devices.
• Apply scientific and engineering principles to complex assignments and select methods, techniques, and evaluation criteria for new assignments.
• Coordinate or direct technical support staff when needed and support the technical development of assigned staff.
• Track and trend data and identify and implement process improvements to improve business measures.
• Investigate product inquiries and develop and implement corrective actions.
• 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, environmental, health, safety, regulatory, and company policies and procedures; ensure subordinate compliance and availability of needed resources when managing staff.
• Perform other duties as assigned.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior