Duties
The Pharmaceutical Process Engineer is responsible for the introduction of new manufacturing processes and products through successful product transfer activities. The role focuses on continuous improvement, operational excellence, and process optimization within a regulated pharmaceutical environment. The Process Engineer applies Lean Six Sigma, Change Management, and data-driven methodologies to improve technical and business processes, resolve deviations, and support sustainable performance improvements across the organization.
Process & Product Transfer
- Lead and support the introduction of new products and manufacturing processes into production.
- Coordinate and execute product transfer projects while ensuring compliance with quality, safety, and regulatory requirements.
- Facilitate knowledge transfer between development, operations, quality, and other cross-functional teams.
Continuous Improvement
- Identify, analyze, and prioritize technical and business process improvement opportunities.
Initiate, coordinate, and implement improvements to processes, systems, and organizational behaviors.
- Drive operational excellence initiatives using Lean Six Sigma methodologies.
- Lead improvement projects and facilitate Kaizen events to enhance efficiency, quality, and productivity.
Investigation & Problem Solving
- Lead or participate in cross-functional investigations related to deviations, non-conformances, and operational issues.
- Perform root cause analyses and develop effective corrective and preventive actions (CAPAs).
Support resolution of complex process and manufacturing challenges.
Change Management & Coaching
- Apply Change Management principles to support successful implementation of new processes and improvements.
- Coach and guide project sponsors, team members, and practitioners in Lean Six Sigma and continuous improvement methodologies.
- Promote a culture of inclusion, collaboration, and continuous learning.
Data-Driven Decision Making
- Analyze process performance data to identify trends, risks, and improvement opportunities.
- Support data-driven decision making through the use of performance metrics and process analytics.
- Ensure effective application of continuous improvement tools and methodologies throughout the organization.