Job Description

PRIMARY PURPOSE: 

We are seeking a highly skilled and driven Process 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.
  • 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.
• 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.

QUALIFICATIONS: 

Required 

• Bachelor’s degree in Engineering or related field. 
• 3-5 years of experience in process engineering, specifically within a GMP-regulated manufacturing environment. 
• Strong expertise in Lean manufacturing principles (5S, Kaizen, VSM, etc.) and Six Sigma methodologies (Black Belt, Green 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: 

• Six Sigma certification (Green Belt, Black Belt). 
• 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

PHYSICAL/ENVIRONMENTAL DEMANDS: The amount of work and physical effort required to perform the duties of your job in a highly demanding manufacturing environment.