Requirements of the Senior Continuous Improvement Engineer:
- Bachelor's degree in engineering or related scientific field
- Lean Six Sigma Black Belt certification strongly preferred, Green Belt acceptable with applicable experience
- A depth of experience managing continuous improvement projects, using Six Sigma tools.
- 5+ years of industry experience and demonstrated knowledge of pharmaceutical manufacturing and corresponding compliance programs ie FDA, NRC, EPA, OSHA.
- Experience in aseptic processes, radiochemistry, equipment procurement, construction and qualification, preferred
- Hands on experience in a cGMP regulated environment.
- Experience with SQL.
- Strong background in project management principles such as estimating, developing, managing schedules and resource plans.
- Superior critical thinking and problem solving skills, ability to thrive in a high stress environment and manage competing priorities.
- Exceptional communications skills and the ability to work cross functionally at all levels within an organization.
Responsibilities of the Senior Continuous Improvement Engineer:
- Identify, characterize and control process variability using good engineering practices and analytical skills using root cause analysis, FMEA, fault trees to identify and mitigate potential process failures.
- Reduce execution time and improve first-time right performance by collaborating cross functionally with Manufacturing, Development and Compliance teams to apply continuous improvement principles (Lean, Six Sigma, etc).
- Achieve reliability goals for newly developed products through designing, testing and implementation of process improvements.
- Ensure manufacturing technical teams and production operators are trained in newly developed processes.
- Participate in root cause investigations of process deviations, design and implement mitigation and containment solutions.
- Author batch records, SOPs, specifications, training documents and prepare protocols, change control, reports and other pertinent regulatory documentation to support reliability activities.
- Develop preventative and predictive maintenance programs for new and critical equipment, assist development teams with equipment validation and qualification.
Occupational Category: 17-2199 Engineers, All Other