Continuous Improvement Engineer

Responsibilities

• Identify and prioritize improvement opportunities through data analysis, process observation, and cross-functional collaboration.
• Lead or support Lean and Six Sigma initiatives (Kaizen events, value stream mapping, DMAIC projects) that reduce waste, improve yield, and increase process reliability.
• Develop and maintain process documentation including SOPs, work instructions, and control plans to sustain improvement gains.
• Apply statistical methods and process capability analysis (Cp, Cpk, SPC) to monitor and improve manufacturing performance.
• Serve as the Engineering team’s primary point of accountability for CAPA coordination, ensuring actions are assigned, tracked, and closed on time.
• Facilitate root cause analysis for engineering-related events using structured tools such as 5-Why, Fishbone, and FMEA.
• Partner with Quality Assurance to ensure CAPA documentation meets regulatory and site quality system requirements.
• Report CAPA status and trends to Engineering leadership; flag systemic issues and support corrective strategies.
• Support site compliance with cGMP/GDP requirements; participate in internal audits and regulatory inspections as assigned.
• Author, review, and approve change control documentation in support of process and equipment changes.
• Collaborate with Quality Assurance on deviation investigations, risk assessments, and product complaints as applicable.
• Ensure all project and improvement activities are executed in alignment with site quality systems and applicable regulatory standards.
• Serve as a resource and subject matter expert for teams navigating quality events and improvement initiatives.
• Present findings, project status, and recommendations to Engineering, Operations, and Quality leadership.
• Contribute to a culture of continuous improvement by coaching team members on CI tools and quality mindset.

Qualifications

• B.S. in Engineering (Chemical, Electrical, Industrial or Mechanical Engineering preferred).
• 5 years of relevant engineering experience in a manufacturing environment.
• Experience supporting or coordinating CAPAs, deviations, or non-conformances in a regulated manufacturing environment.
• Proficiency with root cause analysis methodologies (5-Why, Fishbone, FTA, FMEA).
• Strong analytical and detail-oriented skills with the ability to interpret data and translate findings into actionable improvements.
• Effective written and verbal communication skills; ability to author clear technical documentation.
• Strong project management skills with the ability to manage multiple priorities and hold peers accountable to deadlines.
• Collaborative working style with the ability to influence without direct authority.
• Commitment to quality, continuous improvement, and doing what is right; consistent with the Curia Way.