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 Qualification (IOPQ) activities for autoclaves, parts washers, and related GMP process equipment.
• Prepare, execute, review, and maintain validation documentation, including protocols, reports, risk assessments, and test scripts.
• Collaborate with Engineering, Manufacturing, Quality Assurance, Validation, and Operations teams to support qualification and validation activities.
• Support data analysis from qualification studies and assist with deviation investigations and CAPA implementation where required.
• Ensure qualification documentation is completed in accordance with GMP, FDA, EMA, and internal quality requirements.
• Support change controls, deviation investigations, and regulatory inspection readiness activities related to validated equipment and processes.
• Review equipment operating parameters and qualification requirements to support validation readiness.
• Participate in commissioning, qualification, and validation activities for new or modified equipment.
• Maintain validation lifecycle documentation and ensure records remain accurate and inspection-ready.
• Assist with continuous improvement initiatives related to equipment qualification, process validation, and compliance activities.

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.