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

About the Role

We are looking for a Process Engineer to support downstream manufacturing operations, with a focus on process equipment performance, troubleshooting, qualification, and continuous improvement. This role will work closely with Manufacturing, Engineering, Quality, Validation, and Maintenance teams to ensure safe, compliant, and reliable operations within a GMP-regulated environment.

Responsibilities

• Provide technical support for downstream process equipment used in manufacturing operations, including filtration, chromatography, purification, buffer preparation, transfer systems, and related process skids.
• Monitor equipment performance and identify opportunities to improve reliability, efficiency, compliance, and process robustness.
• Support equipment troubleshooting, breakdown investigations, root cause analysis, and implementation of corrective and preventive actions.
• Participate in equipment qualification, process validation, change control, deviation investigations, and other quality system activities.
• Work closely with cross-functional teams to ensure equipment remains in a validated state and is fit for routine manufacturing use.
• Support new product introduction, process transfer, and equipment readiness activities for downstream operations.
• Review and update SOPs, work instructions, equipment documentation, and technical reports as required.
• Partner with Engineering teams to plan preventive maintenance, calibration, equipment upgrades, and lifecycle management activities.
• Ensure all activities are carried out in compliance with GMP, safety, quality, and data integrity requirements.

Requirements

• Degree in Chemical Engineering, Biotechnology, Pharmaceutical Engineering, Mechanical Engineering, or a related discipline.
• Prior experience in biopharmaceutical, pharmaceutical, life sciences, or GMP manufacturing environments will be advantageous.
• Experience with downstream processing equipment such as chromatography systems, filtration systems, UF/DF systems, buffer preparation systems, single-use systems, CIP/SIP systems, or process skids is preferred.
• Strong understanding of GMP, equipment qualification, deviation management, change control, and validation principles.
• Good troubleshooting, analytical, and problem-solving skills.
• Comfortable working with cross-functional teams in a fast-paced manufacturing environment.
• Strong communication skills and ability to document technical findings clearly.