Process Engineer

Process Engineer III

• This position reports to the Sr. Manager, Engineering. Incumbent will make decisions related to achieving production objectives, and GMP compliance. This position currently does not have direct reports, but can based on the experience level of the selected candidate.
• Required to maintain a portfolio of cost saving/process improvement projects which will consist of (a) active projects, (b) projects in the pipeline, and (c) projects at conceptual stage.
• Responsible for optimizing personnel and SGV (self-guided vehicle) flow in GMP area to ensure the safety of our employees and high quality of our products.
• Perform time studies and calculate Task times to reduce non-value added work.
• Champion Kaizen activities to identify and implement continuous improvement initiatives to improve performance in the following areas: safety, quality, cost, delivery.
• Understand Lean manufacturing concepts like Value Stream mapping, 5S and Visual Workplace to improve quality, labor efficiency, and throughput.
• Participate and/or lead Root Cause Corrective Action activities to permanently eliminate defects. Utilize DMAIC approach to problem solving and non-conformances.
• Responsible for working with various groups (e.g. customers, tech service, quality, production, maintenance) to resolve quality and production issues.
• Generate technical work instructions and SOP’s that will serve as a platform to train manufacturing colleagues.
• Serve as a positive ambassador of change in the organization to motivate work force to produce short and long term demand forecast volumes.
• Participate in Site Environmental efforts/projects and special plant safety activities as needed.

Essential Functions:

• Being a site with lofty and aggressive expansion plans, the candidate will play an instrumental role in the design of the campus’ master plan.
• Create and maintain Visual Management boards detailing performance vs. key metrics and progress vs. active projects and initiatives.
• Monitor and trend Overall Equipment Effectiveness of machines in MFG to identify opportunities for improvement.
• Reengineer processes to optimize product flow, reduce variation, streamline operations and support cost cutting initiatives.
• Take an active role in the development & implementation of a Lean Strategy as it applies to layout work instructions, and work flow.
• Identify and implement initiatives to improve key operational metrics: OEE, MUR, Yield, RFT.
• Oversee the design, implementation and commissioning of key projects in manufacturing to improve safety, quality, cost and capacity.
• Ability to generate documents and graphs in MFG applications and report to management.
• Perform HCM production analysis and develops proposals for process improvements.
• Perform other duties as requested by management.
• Lead Kaizen events to initiate improvements within and between departments.

Other Duties:

• Lead plant tours for customers, special guests/visitors.
• Participate in community events.
• Travel to trade shows, customers, vendors, sister sites as needed. (< 5%)

Qualifications Required:

• Bachelor of Science degree in Chemical, Mechanical or Industrial Engineering.
• Ability to make decisions under time constraints.
• Demonstrated proficiency using Microsoft Suite.
• Excellent written and oral communication skills.
• Public speaking and presentation experience.
• Ability to make sound business decisions in dynamic work environment.
• Proven track record implementing continuous improvement initiatives.
• Experience working in FDA regulated environment is preferred.

Qualifications Desired:

• Ability to analyze and trend data via statistical analysis to predict equipment performance.
• Ability to collaborate with different functional groups and prioritize organizational needs.
• Experience managing a small technical team is a plus.
• Minimum eight (8) years of experience in a lean manufacturing environment.
• Six Sigma Green Belt and/or Black Belt is a plus.