Senior Sterilization Scientist

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at .

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:

Johnson & Johnson MedTech is recruiting for a Senior Sterilization Scientist located in San Angelo Texas! An internal pre-identified candidate for consideration has been identified. However all applications will be considered.

About Surgery

Fueled by innovation at the intersection of biology and technology were developing the next generation of smarter less invasive more personalized treatments.

Are you passionate about improving and expanding the possibilities of surgery Ready to join a team thats reimagining how we heal Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the worlds most prevalent conditions such as obesity cardiovascular disease and cancer. Patients are waiting.

Your unique talents will help patients on their journey to wellness. Learn more at 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 for Ethylene oxide (EO) sterilization area.

Key Responsibilities:

• Be responsible for the EO sterilization execution maintenance activities and 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 the daily sterilization operations; including review of deviations and corrections and trend assessments. Provide technical support to sterilization process.
• Execute periodic qualifications and performance metrics for sterilization process.
• Conduct validation of new processes and products (PQ); establishment of criteria for success.
• Assess impact of product/process change control for sterilization.
• Conduct EO cycle and NPRT re-qualifications.
• Perform periodic product EO residual analysis.
• Work on project teams providing sterilization expertise to help build internal knowledge and aid in business decision-making.
• Perform failure investigations and product impact assessments for non-conformances related to Sterilization parameters. Also provide technical support to CAPAs related to Sterilization issues.
• Contributing member of multidisciplinary project teams in the design development and manufacturing of surgical sutures and other bio surgical applications.
• Contributing member of project teams in the development and manufacturing of medical devices.
• Plans conducts and directs engineering projects or studies including complete projects requiring advanced knowledge of a specialized field.
• Applies comprehensive and diverse knowledge of scientific principles and practices within broad assignment areas.
• May coordinate and direct activities of technical support staff (salary and wage) and is responsible for technical development of assigned staff.
• Track and trend data identify and implement process improvements to improve business measures.
• Investigate product inquiries develop and implement appropriate corrective actions.
• Analyzes data and complex situations involving the evaluation of tangible and identifiable variables to arrive at creative and effective solutions.
• Exercises 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 / engineers.
• Serve as Back-up signature authority for Base Business Sterilization team.
• Comply with all applicable quality management system environmental safety and occupational health policies. (for example ISO 13485 ISO14001 & OSHAS18001).
• Responsible for communicating business related issues or opportunities to next management level
• Responsible for following all Company guidelines related to Health Safety and Environmental practices as applicable.
• For those who supervise or manage a staff responsible for ensuring that subordinates follow all Company guidelines related to Health Safety and Environmental practices and that all resources needed to do so are available and in good condition if applicable
• Responsible for ensuring personal and Company compliance with all Federal State local and Company regulations policies and procedures.
• Performs other duties assigned as needed.

Qualifications

Education:

• A minimum of a Bachelors degree in Science Engineering Bio Medical or equivalent related field is required

Experience and Skills:

Required:

• 2-4 years relevant work experience
• Must have experience within the medical device industry.
• Broad understanding of environmental control packaging and manufacturing process impact on sterility assurance.
• Thorough experience in sterilization processes; Ethylene Oxide process knowledge.
• Proven experience in change control process within a regulated industry including development implementation and test method validation.
• Knowledgeable in ISO FDA and other regulated standards.
• Advanced computer skills (Microsoft Office) and use of software application(s). Experience with LIMS or ERP is preferred.
• Working knowledge of CAPA and non-conformance systems is required.
• Proficient with leadership in project management and technical expertise.
• Position requires 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.
• Must demonstrate a mastery of the analytical skills and professional judgment required to resolve major technical issues.
• Must be capable of making effective management level presentations writing formal reports dealing with both technical and business implications and preparing project plans while identifying and understanding the interrelationships

Other:

• English Fluency required
• 10% Travel a possibility

For more information on how we support the whole health of our employees throughout their wellness career and life journey please visit .

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race color religion sex sexual orientation gender identity age national origin disability protected veteran status or other characteristics protected by federal state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants needs. If you are an individual with a disability and would like to request an accommodation external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource.

Required Skills:

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 Science Technology Engineering and Math (STEM) Application Situational Awareness Supply Planning Technical Research Technologically Savvy Validation Testing

Required Experience:

Senior IC