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.

What You'll do as a Senior Process Manufacturing Engineer

• ◆Support the execution of protocols to comply with FDA and cGMP

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.

• ✓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 Pharmaceutical Manufacturing.
• ✓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.