Job Description

The Process Engineer is responsible for driving continuous process improvements related to Safety, Quality, Delivery, and Cost (SQDC) across manufacturing operations. The role focuses on equipment validation, process optimization, troubleshooting, capacity improvement, and compliance with Quality Management System (QMS), GMP, and IVD regulatory requirements.

Key Responsibilities

• Lead installation, qualification, and validation of new and existing equipment and manufacturing processes.
• Develop, execute, and maintain validation plans, protocols, reports, SOPs, and other QMS documentation.
• Drive continuous improvement projects using Lean, Six Sigma, Kaizen, and DBS methodologies.
• Monitor equipment performance, efficiency, uptime, downtime, and process capability.
• Perform root cause analysis and implement corrective and preventive actions (CAPA).
• Analyze process data and establish process limits, specifications, and control strategies.
• Collaborate with Manufacturing, Quality, Product Transfer, Controls & Automation, and other cross-functional teams.
• Support new product introductions (NPI) and technology transfers.
• Train operators, contingent staff, and cross-functional teams on equipment, processes, and quality requirements.
• Ensure compliance with GMP, ISO 13485, IVDD/IVDR, and company procedures

Join our winning team today. Together, we’ll accelerate the real-life impact of tomorrow’s science and technology. We partner with customers across the globe to help them solve their most complex challenges, architecting solutions that bring the power of science to life.

For more information, visit www.danaher.com.