Staff Scientist

About the role

We are searching for the best talent for a Staff Scientist in San Angelo, Texas!

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.
• Audit the impact of product and process change controls for sterilization.
• Perform periodic product EO residual analysis.
• Participate on project teams by providing sterilization expertise to build internal knowledge and support business decision-making.
• Conduct failure investigations and product impact assessments for non-conformances related to sterilization parameters.
• Lead or provide technical support for CAPAs related to sterilization issues.
• Provide sterilization expertise to build internal knowledge and support business decision-making.
• Exercise independent judgment in selecting methods, techniques, and evaluation criteria for obtaining results on new assignments.
• 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.
• Analyze data and complex situations involving evaluation of tangible and identifiable variables to arrive at creative and effective solutions.
• 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: 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 a team. Mastery of analytical skills and professional judgment required to resolve major technical issues. Ability to deliver effective management-level presentations, write formal reports addressing technical and business implications, and prepare project plans while identifying and understanding interrelationships among related disciplines and key activities. Knowledge of FDA, BSI, ISO, and GMP requirements.
• Preferred Experience: Experience with LIMS or ERP systems is preferred. Experience providing sterilization expertise on cross-functional medical device project teams is preferred. Experience supporting EO residual analysis, EO cycle re-qualifications, NPRT re-qualifications, and sterilization performance metrics is preferred.