Senior Process Manufacturing Engineer

Mentor, Ohio, United States
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 (DOE) for the purpose of scale-up, troubleshooting and modifications of new and existing processes.
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. Interfaces 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. Establishes and maintains 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, Skills, and Abilities Necessary
A minimum of five (5) years of experience in process engineering or equivalent.

We value our employees and are committed to providing a comprehensive benefits package that supports your health, well-being, and financial future.

Here is a brief overview of what we offer

Extensive paid time off and (9) added holidays
Excellent healthcare, dental, and vision benefits
Additional add on benefits/discounts for programs such as pet insurance
Tuition reimbursement and continued educational programs
Excellent opportunities for advancement in a stable long-term career

Pay range for this opportunity is $92,600 - $114,500. This position is eligible for bonus participation.
Minimum pay rates offered will comply with county/city minimums, if higher than range listed. Pay rates are based on a number of factors, including but not limited to local labor market costs, years of relevant experience, education, professional certifications, foreign language fluency, etc.
STERIS offers a comprehensive and competitive benefits portfolio. Click here for a complete list of benefits:
Open until position is filled.
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 and life sciences products and services around the globe. For more information, visit .
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 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.
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