Aseptic Manufacturing Startup Engineer

WuXi Biologics; Singapore; On-site; SGD 55,000 - 90,000; Full time

Job summary

WuXi Biologics in Singapore is seeking an Operations Support Engineer to aid the startup of a state-of-the-art aseptic manufacturing facility, focusing on documentation, training coordination, and site systems setup.

You will work with MSAT, Validation, QA, and QC to support NPI, tech transfer, and process validation, ensuring readiness for initial production and compliance with cGMP standards.

Note: Shuttles to the site are available at selected MRT stations.

Qualifications

• Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences, or related field.
• 3–5 years of experience in pharmaceutical or biotech manufacturing.
• Basic understanding of cGMP and pharmaceutical manufacturing processes.
• Exposure to aseptic processing or cleanroom environment is an advantage.
• Familiarity with documentation practices (SOPs, batch records) is preferred.
• Good communication and coordination skills.
• Willingness to learn and work in a fast-paced startup environment.
• Team player with strong attention to detail.

Responsibilities

• Support installation, commissioning, and qualification of manufacturing equipment from an operational readiness perspective
• Assist in preparation and maintenance of operational documents, including SOPs, Master Batch Records (MBRs), and Work Instructions (WIs)
• Coordinate with service providers and contractors (e.g., cleaning/disinfection, gowning laundry) to ensure readiness and compliance
• Support execution of environmental and utilities monitoring activities in accordance with procedures
• Assist in onboarding and coordinating training for manufacturing personnel
• Track training completion and support qualification of operations staff
• Provide support during system go-live and initial manufacturing phases
• Ensure compliance with cGMP and internal quality standards during startup and routine operations
• Work closely with MSAT, Validation, QA, and QC teams to support NPI, technology transfer, and validation activities
• Support audit and inspection readiness activities (e.g., documentation, mock inspections)
• Participate in deviation investigations and root cause analysis (e.g., 5 Whys, Fishbone)
• Interface with internal stakeholders and support client-related activities when required
• Support site readiness timelines and operational milestones
• Perform other duties as assigned during startup phase

Skills

Communication

Coordination

Education

Bachelor’s degree in Pharmaceutical Sciences, Chemical Engineering, Biological Sciences, or related field

Job description

WuXi Biologics in Singapore is seeking an Operations Support Engineer to aid the startup of a state-of-the-art aseptic manufacturing facility, focusing on documentation, training coordination, and site systems setup.

You will work with MSAT, Validation, QA, and QC to support NPI, tech transfer, and process validation, ensuring readiness for initial production and compliance with cGMP standards.

Note: Shuttles to the site are available at selected MRT stations.