Job Description

Description:

The Continuous Improvement Engineer is responsible for optimizing manufacturing processes, improving operational efficiency, reducing costs, and ensuring compliance with regulatory standards within pharmaceutical production environments. This role focuses on process improvement, capacity planning, workflow optimization, and implementation of lean manufacturing principles while maintaining strict adherence to Good Manufacturing Practices (GMP) and regulatory requirements.

Essential Functions:

• Lean Project Leadership and DMAIC Execution: Lead cross-functional teams through DMAIC roadmap to drive systemic process improvements. Utilize Value Stream Mapping (VSM) to identify and eliminate the 8 Wastes (DOWNTIME) in conjunction with Design for Manufacturing (DFM) and Design for Assembly (DFA) principles. Execute Kaizen events focused on Lean/Six Sigma methodologies, 5S, TPM, Visual Management and Standardized Work to achieve efficiency improvements while maintaining compliance with regulatory standards.
• Compliance, Validation & Regulatory Support: Ensure manufacturing processes comply with GMP requirements and regulatory authorities. Support equipment and process validation activities, including: Installation Qualification (IQ): Verify proper installation according to approved specifications. Operational Qualification (OQ): Confirm equipment operates within defined parameters. Performance Qualification (PQ): Ensure consistent performance under routine production conditions. Participate in protocol development, execution, documentation, audits, and change control activities. Support risk assessments and continuous compliance initiatives.
• Statistical Analysis and Data Reporting: Collect and analyze production and validation data to identify trends. Develop KPIs and performance dashboards to monitor process stability and capability indices (Cpk/Ppk). Apply statistical tools (Minitab) and data-driven insights to perform Root Cause Analysis (RCA) and trend validation.
• Cost Reduction & Continuous Improvement: Identify and execute cost reduction initiatives targeting scrap, rework, and deviations without compromising compliance. Translate operational wins into financial impact, focusing on annualized revenue increases and margin expansion.
• Conduct bottleneck analysis and line balancing to optimize throughput and manpower utilization. Perform production capacity analysis and forecasting.

Additional Responsibilities:

• Other duties as assigned.