Jr. Process Engineer

Job Summary

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.

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

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.