Senior Continuous Improvement Engineer

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.