Lean CI Engineer: Process Optimization & CAPA Lead

Continuous Improvement Engineer in Springfield, MO

Build your future at Curia, where our work has the power to save lives.

Job Description

Continuous Improvement Engineer in Springfield, MO

Build your future at Curia, where our work has the power to save lives.

The Continuous Improvement Engineer is a key driver of engineering excellence and operational performance at our manufacturing site. This role leads high-impact process improvement initiatives, serves as the Engineering team’s CAPA lead, and partners with cross-functional teams to identify, execute, and sustain meaningful improvements across the facility.

Curia is a global contract development and manufacturing organization (CDMO) with over 30 years of experience partnering with pharmaceutical and biotech companies to provide life-saving treatments to patients. At Curia, we are on a mission to advance our customers’ therapies from curiosity to cure and ultimately to improve patients’ lives.

We proudly offer

• Generous benefit options (eligible first day of employment)
• Paid training, vacation and holidays (vacation accrual begins on first day of employment)
• Career advancement opportunities
• Education reimbursement
• 401K program with matching contributions
• Learning platform
• And more!

• 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.

• Perform all documentation in compliance with ALCOA++ principles and site SOPs.
• Adhere to applicable cGMP documents including SOPs, batch records, protocols, change controls, and controlled forms.
• Keep all required cGMP training current and escalate quality concerns along with proposed solutions to the Quality department.

• 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…