Aseptic Assembly & Packaging Engineer - Startup Ready

WuXi Biologics; Singapore; On-site; SGD 120,000 - 170,000; Full time

Job summary

WuXi Biologics is seeking an Engineering professional to support startup and operational readiness of a state-of-the-art aseptic manufacturing facility with multiple production lines. The role reports to the Assembly and Packing Supervisor and supports assembly and packing processes for products produced through automated and manual systems.

The engineer will assist in equipment commissioning, qualification activities, process implementation, and cross-functional startup initiatives while

Qualifications

• Diploma or Bachelor’s degree in pharmaceutical sciences, chemical engineering, biological sciences or related field.
• 5–8+ years of experience in assembly and packaging drug product manufacturing.
• Working knowledge of cGMP requirements and global regulatory standards.
• Familiarity with equipment qualification, process validation, engineering runs, media fills and commercial manufacturing operations.
• Proficiency in manufacturing systems and knowledge of quality systems.

Responsibilities

• Support startup, qualification, validation, and operational readiness activities for Assembly, Visual Inspection, and Packaging operations.
• Execute manufacturing and inspection activities in compliance with cGMP, SOPs, batch records, and regulatory requirements.
• Support equipment qualification, validation, troubleshooting, maintenance, and lifecycle management.
• Participate in visual inspection programs, including defect management, POD studies, QRA assessments, and qualification activities.
• Support engineering runs, media fills, process validation, PPQ, clinical manufacturing, and commercial production.
• Collaborate with cross-functional teams to support NPI, technology transfer, process improvements, and product lifecycle management.
• Investigate manufacturing issues, support CAPAs, root cause analysis, and continuous improvement initiatives.
• Prepare and maintain GMP documentation, including SOPs, batch records, protocols, reports, and training records.
• Support QMS activities, including Deviations, CAPAs, Change Controls, Risk Assessments, audits, and inspection readiness.
• Ensure compliance with FDA, EMA, PIC/S, ICH, Annex 1, customer, and cGMP requirements.
• Support training and qualification of manufacturing and inspection personnel.
• Interface with customers and stakeholders to support project execution and technology transfers.
• Ensure safe, compliant, and timely execution of assigned manufacturing and inspection activities.

Education

Diploma or Bachelor’s Degree in Pharmaceutical Sciences / Chemical Engineering / Biological Sciences or related field

Job description

WuXi Biologics is seeking an Engineering professional to support startup and operational readiness of a state-of-the-art aseptic manufacturing facility with multiple production lines. The role reports to the Assembly and Packing Supervisor and supports assembly and packing processes for products produced through automated and manual systems.

The engineer will assist in equipment commissioning, qualification activities, process implementation, and cross-functional startup initiatives while