The Senior Process Engineer is responsibile for developing a strategy and executing plan to deliver process performance improvements related to Safety, Quality, Delivery, and Cost of a manufacturing process or line. Develops strategy, change management plan, and execution plan to improve flow of products. Leverages process knowledge to identify opportunities / solutions to improve throughput capacity by reducing impact of constraints. Is responsible for driving operators’ engagement and for developing Lean and Six Sigma capabilities through coaching and mentoring. Follows and observes all regulatory requirements (GMP’s, ISO, FDA, internal policies) applicable to area of responsibility. Has extensive experience with bulk liquid manufacturing and
lyophilized reagents and developing process documentation.
- Apply knowledge of relevant continuous improvement tools and approaches to increase production up-time, minimize unplanned maintenance, minimize work in process inventories (WIP) or plant inventories, and implement cost reduction initiatives across equipment and labor
- Assist in creating and updating manufacturing SOPs/Work Instructions.
- Provide training to Manufacturing personnel
- Seek and implement process improvements within Manufacturing
- Recognize machine operating conditions and requirements for optimum production runs and can troubleshoot and resolve basic line performance issues
- Identify constraints in, or non-conformances resulting from, the production process through analysis of material, people and information movement/flow
- Understand product cost drivers by interpreting product bill of materials and cost sheets to ensure adherence to projected cost
- Leverage knowledge of product costs and drivers and Design to Value concepts to effectively participate in cross-functional teams pursuing product cost improvement initiatives
- Effectively interface with other engineering disciplines, such as Controls & Automation engineering and New Product Introduction teams
- Develop and deliver oral and written communications around process improvement projects
- Organize an analytical approach to problem solving with familiarity with FDA and GMP
- Understanding of financial processes (standard cost development) and business planning
- In depth understanding of production and quality control techniques (such as CFM and TQM)