Industrial Engineer

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 implementing lean manufacturing principles while maintaining strict adherence to Good Manufacturing Practices (GMP) and regulatory requirements.

Essential Functions:
- Lead cross-functional teams through DMAIC to drive systemic process improvements; use Value Stream Mapping (VSM) to eliminate the 8 Wastes (DOWNTIME) using DFM/DFA; execute Kaizen events (Lean/Six Sigma), including 5S, TPM, Visual Management, and Standardized Work.
- Ensure processes comply with GMP and regulatory authorities; support IQ/OQ/PQ validation, protocol development/execution/documentation, audits, and change control; support risk assessments.
- Collect/analyze production and validation data; develop KPIs/dashboards to monitor Cpk/Ppk; use Minitab for statistical analysis, Root Cause Analysis (RCA), and trend validation.
- Identify/execute cost reduction initiatives targeting scrap, rework, and deviations; perform bottleneck analysis, line balancing, and production capacity analysis/forecasting.

Qualifications:
- Education: BS/BA in Mechanical or Electrical Engineering (Required); MS/MA (Preferred).
- Experience: 3+ years in manufacturing/pharmaceuticals/engineering or related field.
- Skills/Knowledge: Strong MS Office and MPR (SAP preferred); Black Belt or Green Belt experience required; knowledge of cGMP/FDA and regulatory compliance; Lean Six Sigma certification preferred; AutoCAD preferred.

Additional Requirement:
- Successful completion of an OSHA-compliant Respirator Fit Test.