全职 Process Engineer 工作, 薪水, Coalesce Management Consulting 公司招聘中 - Ricebowl

About the Role

We are seeking a Process Engineer to support manufacturing operations within a leading biopharmaceutical facility. The successful candidate will work closely with cross-functional teams to ensure reliable, compliant, and efficient manufacturing processes while driving continuous improvement initiatives.

Key Responsibilities:

• Support engineering remediation activities across designated manufacturing systems, including Deviations, CAPAs, and Change Controls, through the development of Failure Mode and Effects Analysis (FMEA), Hazard and Operability (HAZOP) assessments, and Root Cause Analyses (RCA).
• Serve as the Subject Matter Expert (SME) during manufacturing tier meetings, driving issue resolution, risk mitigation, and cross-functional alignment on operational improvements.
• Act as a Technical System Owner for upstream and downstream manufacturing equipment and critical unit operations, partnering with cross-functional teams to execute equipment qualification and validation activities, including FAT/SAT, Installation Verification, IOQ, PQ, and Risk Verification (RV).
• Provide troubleshooting support and technical expertise for critical process instrumentation, successfully resolving complex issues related to process performance.
• Support Change Control records and Preventive Maintenance (PM) programs within CMMS/SAP, ensuring compliance with quality, regulatory, and operational standards.
• Develop, review, and maintain technical documentation, including standard operating procedures (SOPs), work instructions, and engineering reports.
• Review technical and vendor documentation to ensure alignment with user requirements, regulatory expectations, and operational standards.
• Oversee engineering project execution activities, including installation, commissioning, and system modifications, ensuring projects are delivered safely, on schedule, and within scope.

Preferred Experience

• Bachelor’s degree in Engineering, or related field (preferred).
• Strong vendor management, process and manufacturing, and equipment lifecycle management experience.
• Good organizational, problem-solving, and communication skills