Upstream Manufacturing Engineer

1. Job Summary

As MFG Engineer/ Senior Engineer, you will be expected to be a subject matter expert in all Upstream process and in process equipment. Detailed knowledge of the process will be vital to ensure optimum process operations, as well as a high level of understanding of GDP. The responsibility includes specific actions during project technology transfers and troubleshooting during GMP manufacturing. The candidate will be communicating with internal team and client on project status and be responsible to support/lead any quality events occurred during GMP production.

2. Responsibilities

• Serve as a SME to support cGMP manufacturing from process engineering perspectives, with responsibilities of troubleshooting process equipment, deviation investigation, CAPA implementation.
• Collaborate with internal stakeholders and external partners to support technology transfer, scale-up, and production activities for mAb upstream MFG processes. Provide opinion during technology transfer meetings on technical or operational challenges.
• Provide input and support on equipment installation, start-up, operation and troubleshooting to support the introduction of new equipment. Work with cross functional teams to facilitate the development and validation of mAb Upstream Manufacturing.
• Support the implementation of new technologies, automation systems, and digital solutions to enhance the organization's efficiency, productivity, and innovation.
• Support MFG upstream process equipment maintenance system development, including spare parts inventory, calibration and preventive maintenance program, and continuous validation requirements.
• Perform engineering assessments, root cause analyses, and troubleshooting to resolve technical issues, improve process performance, and ensure product quality and compliance.
• Provide technical expertise, mentorship, and guidance to junior engineers and team members, fostering a culture of continuous learning and professional development.
• Key member of Manufacturing execution team for WuXi XDC Singapore. Will play an important role in the execution of the business plans, ensuring cross functional collaboration.
• Perform all core production tasks in the areas of upstream and all ancillary tasks that related to production activities.
  Conducts all activities that are in accordance with Company policies & SOPs, WuXi values, & global regulatory guidelines, environmental guidelines, and controlled documents, etc.
• Collaborate with production shifts for continuous process improvement for both on floor operations and manufacturing process, reducing the production cost and enhance productivity.
• Review mAb upstream technology transfer documents generated by MSAT. Author, review and revision of GMP documents include but not limited to BOM/STPL/PFD/SOP/OJT/MBR/Batch report, etc.
• Participate in the drafting and reviewing of template or project batch records to ensure smooth on-floor activities. Provide insight on new practices or new equipment on project meetings if needed.
• Will be flexible to take on additional tasks and responsibilities at the discretion of the MFG Lead.
• Shift working may be required. The shift pattern may be varied according to business requirements and will typically require weekend work and night shift.
• Will be flexible to take overtime work and may work during holidays.

2. Qualifications

Technical Competencies

• PhD; Master’s or Bachelor’s degree in Biology, Chemistry, Chemical/Pharmaceutical Engineering, or other related Science/Engineer major.

Experience

• Minimum 1-year large scale biologics manufacturing hands on experience or minimum 2-year biologics process development hands on experience for Master degree;
• Minimum 4-year large scale biologics manufacturing hands on experience or minimum 6-year biologics process development hands on experience for Bachelor’s degree.
• Basic knowledge of regulatory GMP requirement for production of biopharmaceutical Drug Substance.
• Experience in CRDMO company would be a plus.