Senior Process Manufacturing Engineer

The Senior Process Manufacturing Engineer in our St. Louis, MO location is responsible for establishing themanufacturing process capability for new/reformulated products. In this role you will support the execution ofequipment qualification, cleaning, and process validation program. Prepare and revise batch records, operatinginstructions, and cleaning instructions. Conduct process improvement studies in the areas of operationalproductivity, process control, quality processing, employee safety, process yield improvement, and environmentalimpact in a lean environment. Test new technologies, processes, controls or prototype equipment and supportimplementation 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 St. Louis, MO location.

• 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 andintroduction of new/reformulated products.
• Interface with Product Development and Production to bring these processes from the research laboratorythrough scale-up full-scale manufacturing.
• Responsible for research and testing of new technologies or processes appropriate for support ofnew/existing product manufacture.
• Establish and maintain set point controls.
• Support Project Engineering to obtain approval for Capital Appropriation Requests, design specifications andequipment installation.
• Provide personnel training, development of manufacturing instructions and start-up of newprocesses/equipment.
• Responsible for conducting process studies, identifying opportunities for improvement and supportingimplementation 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, engineeringanalysis, conclusions and recommendations.
• Monitor and provide solutions in terms of quality, yields, throughput, cycle times, process parameters, cGMPcompliance, and safety and environmental requirements.
• Apply structured, technical problem-solving methodologies such as DMAIC, six sigma green belt/black beltstatistical 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, includingchemical and biological formulation, filling, packaging, and quality operations.
• Employ key project management principles including establishing and tracking timelines, identifying andmitigating risks, communicating across teams at all levels.

Required:

• Bachelors degree in Engineering.
• Minimum five (5) years in process engineering or equivalent.
• Background in biochemical or chemical engineering, or microbiology.
• Project leadership skills, technical skills, and organization skills required.
• Experience with FDA, and GMP regulated operations, such as Medical Devices or PharmaceuticalManufacturing.
• Good communication skills and interpersonal skills.
• Proven proficiency in facilitating problem solving and other team-based root cause analysis (RCA).
• Ability to generate detailed, high quality technical documentation to capture and communicate designs.
• Ability to influence team members to perform at exceptional levels.

Preferred:

• Lean Six Sigma certification such as Green Belt or Black Belt, preferred.

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

Here is just a brief overview of what we offer:

• Market Competitive pay
• Extensive Paid Time Off and added Holidays
• Excellent Healthcare, Dental and Vision benefits
• Long- and Short-Term Disability coverage
• 401(k) with a company match
• Maternity and Paternity Leave
• Additional add- on benefits / discounts for programs such as Pet Insurance
• Tuition Reimbursement and continuing education programs
• Excellent opportunities for advancement in a stable long-term career

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Pay range for this opportunity is$92,650.00-$119,900.00. [ACTION REQUIRED - REMOVE IF NOT APPLICABLE:] 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: STERIS 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 View phone number on click.appcast.io. 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.