Senior Process Manufacturing Engineer

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.

This is an onsite position that may require 5-10% travel domestically as well as international.

• 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 theseprocesses 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.

• 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
• Lean Six Sigma certification such as Green Belt or Black Belt - preferred
• Proven proficiency in facilitating problem solving and other team-based RCA
• Generates detailed, high quality technical documentation to capture and communicate designs.
• Influences other team members to perform at exceptional levels

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