Senior Process Manufacturing Engineer

STERIS CORPORATION • Mentor, OH • 12h ago

Senior Process Manufacturing Engineer
Req ID:
52559
Job Category:
Engineering
Location:
Mentor, OK, US, 44060
Workplace Type:
Onsite
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
The Senior Process Manufacturing Engineer in our Mentor, Ohio location is responsible for establishing the manufacturing process capability for new/reformulated products. In this role you will support the execution of equipment qualification, cleaning, and process validation program. 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 proto@type 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 (DOE) for the purpose of scale-up, troubleshooting and modifications of new and existing processes.
This position requires that you work onsite Monday through Friday during core business hours in our Mentor, OH location.
What You'll do as a Senior Process Manufacturing Engineer
Support the execution of protocols to comply with FDA and cGMP requirements for equipment qualification, cleaning and process validations.
Responsible for the development of lean culture and institution of lean principles.
Develop plans, design experiments, and schedules for establishing manufacturing process capability and introduction of new/reformulated products.
Interface with Product Development and Production to bring these processes from the research laboratory through scale-up full-scale manufacturing.
Responsible for research and testing of new technologies or processes appropriate for support of new/existing product manufacture.
Establish and maintain set point controls.
Support 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.
Resolve manufacturing deficiencies through troubleshooting and implementation of corrective actions.
Develop and submit 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.
Apply structured, technical problem-solving methodologies such as DMAIC, six sigma green belt/black belt statistical analysis, etc. to confirm root causes of problems.
Implement corrective and preventative actions to solve root causes and prevent recurrence, reduce variation, and drive improvement in quality and other key KPI's.
Serve as Subject Matter Expert (SME) providing deep technical insights into operations processes, including chemical and biological formulation, filling, packaging, and quality operations.
Employ key project management principles including establishing and tracking timelines, identifying and mitigating risks, communicating across teams at all levels.
The Experience, Sk

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