At STERIS, we help our Customers create a healthier and safer world by providing innovative healthcare and life science product and service solutions around the globe.

Position Summary

Responsible for establishing manufacturing process capability for new/reformulated products. Support the execution of equipment qualification, cleaning, and process validation programs. Prepare and revise batch records, operating instructions, and cleaning instructions. Conduct process improvement studies in the areas of operational productivity, process control, quality processing, employee safety, process yield improvement, and environmental impact in a lean environment. Test new technologies, processes, controls or prototype equipment and support implementation as appropriate to optimize liquid blending systems. Provide indirect supervision of technicians, interns and operators as required. Develop P&ID’s in support of validation efforts. Develop design of experiment for the purpose of scale-up, trouble shooting, and modifications of new and existing processes.

Duties Support the execution of protocols to comply with FDA and cGMP requirements for equipment qualification, cleaning and process validations. Responsible for development of lean culture and institution of lean principles. Develops plans, design of experiments, and schedules for establishing manufacturing process capability and introduction of new/ reformulated products. Interfaces with Product Development and Production to bring these processes from the research laboratory through scale-up into full scale manufacturing. Responsible for research and testing of new technologies or processes appropriate for support of new/existing product manufacture. Supports Project Engineering to obtain approval for Capital Appropriation Requests, design specifications and equipment installation.  Provide personnel training, development of manufacturing instructions and start-up of new processes/equipment. Responsible for conducting process studies, identifying opportunities for improvement and supporting implementation of findings to optimize liquid blending systems. Resolves specific manufacturing deficiencies through troubleshooting and implementation of corrective actions. Develops and submits written reports including, objective, experimental, compilation of data, engineering analysis, conclusions and recommendations. Monitor and provide solutions in terms of quality, yields, throughput, cycle times, process parameters, cGMP compliance, and safety and environmental requirements. Required Experience Bachelor's degree in Engineering. One to five years’ experience in process engineering, production support and/or batch chemical processing. Project leadership skills, technical skills and organizational skills required.  Familiarity with current Good Manufacturing Practices (cGMPs) and familiarity with FDA regulations preferred.  Good communications and interpersonal skills needed. Experience in basic unit operations required.

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STERIS is a leading global provider of products and services that support patient care with an emphasis on infection prevention.  WE HELP OUR CUSTOMERS CREATE A HEALTHIER AND SAFER WORLD by providing innovative healthcare, life sciences and dental products and services. STERIS is a $5 billion, publicly traded (NYSE: STE) company with approximately 17,000 associates and Customers in more than 100 countries.

If you need assistance completing the application process, please call 1 (440) 392.7047. This contact information is for accommodation inquiries only and cannot be used to check application status.

STERIS is an Equal Opportunity Employer.  We are committed to equal employment opportunity and the use of affirmative action programs to ensure that persons are recruited, hired, trained, transferred and promoted in all job groups regardless of race, color, religion, age, disability, national origin, citizenship status, military or veteran status, sex (including pregnancy, childbirth and related medical conditions), sexual orientation, gender identity, genetic information, and any other category protected by federal, state or local law.  We are not only committed to this policy by our status as a federal government contractor, but also we are strongly bound by the principle of equal employment opportunity.

The full affirmative action program, absent the data metrics required by § 60-741.44(k), shall be available to all employees and applicants for employment for inspection upon request. The program may be obtained at your location’s HR Office during normal business hours.