SENIOR CONTINUOUS IMPROVEMENT ENGINEER

PRIMARY PURPOSE:

We are seeking a highly skilled and driven Continuous Improvement Engineer with expertise in driving continuous improvement and Lean principles in a GMP manufacturing environment. The ideal candidate will have a strong background in process optimization, efficiency enhancement, and the implementation of Lean tools to improve overall operational performance while ensuring strict adherence to regulatory and quality standards. This is a key role aimed at ensuring the continuous enhancement of operations processes, driving cost reduction, improving quality, and maximizing productivity.

MAJOR DUTIES AND RESPONSIBILITIES:

Process Improvement & Optimization:

Lead continuous improvement initiatives to streamline manufacturing processes, eliminate waste, and enhance overall process efficiency.

Analyze current production processes to identify opportunities for optimization using Lean and Six Sigma methodologies.

Collaborate with cross-functional teams to implement improvements, ensuring the changes align with production goals and regulatory requirements.

Lean & Six Sigma Implementation:

Apply Lean tools such as Value Stream Mapping, 5S, Kaizen, TPM (Total Productive Maintenance), and other Lean methodologies to drive operational excellence.

Lead process improvement projects using DMAIC (Define, Measure, Analyze, Improve, Control) or DMADV (Define, Measure, Analyze, Design, Verify) approaches, focusing on improving quality, reducing costs, and increasing throughput.

Facilitate improvements using strong problem-solving skills including use of SIPOC, 5-Why's, Ishikawa diagrams, 8D and A3 advanced problem solving for root cause analysis (RCA).

GMP Compliance:

Ensure that all process improvements are implemented in full compliance with GMP guidelines and other regulatory requirements.

Maintain up-to-date knowledge of GMP regulations and standards to ensure manufacturing processes are always in compliance.

Data-Driven Decision Making:

Collect and analyze process data to monitor and evaluate key performance indicators (KPIs), identifying trends and areas for improvement.

Strong statistics foundation including us of Pareto analyses, SPC and basic Cpk analysis

Develop and maintain metrics for tracking the success of process improvements, presenting results and recommendations to management.

Training & Development:

Train and mentor production teams on Lean principles, problem-solving techniques, and process improvement methodologies.

Develop and deliver training programs to ensure all team members understand and can implement continuous improvement practices effectively.

Mentor other engineers in continuous improvement competencies

Collaboration & Support:

Work closely with engineering, operations, quality, and maintenance teams to ensure successful project implementation and sustained improvements.

Provide technical guidance and troubleshooting support to resolve complex process-related issues in a timely manner.

Lead teams to deliver improvements to the business

Other duties as assigned. QUALIFICATIONS:

Required

Bachelor's degree in Engineering or related field.

10+ years of experience in process engineering, specifically within a GMP-regulated manufacturing environment.

Six Sigma certification (Green/Black Belt).

Strong expertise in Lean manufacturing principles (5S, Kaizen, VSM, etc.) and Six Sigma methodologies (Black Belt, or equivalent).

Proven track record of leading continuous improvement initiatives in a manufacturing environment.

Strong analytical skills, with experience using statistical tools and process modeling software.

Excellent project management skills with the ability to manage multiple initiatives concurrently.

Strong communication and interpersonal skills with the ability to collaborate effectively at all levels of the organization.

Ability to work independently and make data-driven decisions. Preferred:

Experience in pharmaceutical or biotechnology manufacturing environments.

Experience in training teams on Lean methodologies and process improvements.

Experience with Hoshin Kanri or Strategy Deployment processes