DS Manufacturing Engineer - Bioconjugation

WuXi XDC; Singapore; On-site; SGD 40,000 - 65,000; Full time

Job summary

WuXi XDC in Singapore is seeking a Biopharmaceutical Manufacturing Operator to execute GMP-compliant operations and support conjugation/purification processes. The role requires 1–2 years of hands-on experience in biopharmaceutical manufacturing and knowledge of sterile production and quality systems.

Ideal candidates will be familiar with Single-Use Technologies and downstream processing, and be capable of supporting audits, documentation, and project readiness.

Qualifications

• Bachelor degree required in relevant field.
• 1–2 years hands-on biopharmaceutical manufacturing experience.
• Familiar with GMP regulations from HSA, FDA, NMPA, EU, and ICH.
• Solid understanding of sterile pharmaceutical manufacturing and quality systems.
• Familiar with Single-Use Technologies (SUT) and downstream processing or bioconjugation.
• Experience with documentation and record-keeping in digital systems.

Responsibilities

• Execute manufacturing operations in compliance with SOP and MBR requirements and ensure records are completed accurately and timely.
• Perform drug conjugation reactions, purification, weighing, sampling, and sample management.
• Operate and support equipment for conjugation and purification to ensure safe, efficient operations.
• Participate in FAT, SAT, and IOPQ activities and support facility maintenance.
• Draft, review, and maintain SOPs and related process documentation.
• Support deviations, change control, audits, and other quality system processes.
• Assist in audits and inspections with documentation and operational support.
• Utilize electronic systems (MasterControl, LIMS, MDH, OneBPM) for records and tracking.
• Act as supervisor delegate in absence of supervisor and coordinate tasks.
• Support daily operations, shift execution, and stakeholder communications.
• Assist in project production readiness, scheduling, and material planning.
• Assist in drafting and reviewing BOMs to ensure timely material availability.
• Complete other ad-hoc tasks to support operations.

Skills

GMP knowledge

Biopharmaceutical manufacturing

Sterile processing

Single-Use Technologies (SUT)

Quality systems

Documentation

Cross-functional collaboration

Auditing support

Education

Bachelor's degree in Chemistry/Biochemistry/Biology/Pharmaceutical/Biological Engineering or related field

Tools

MasterControl

LIMS

MDH

OneBPM

Job description

1. Manufacturing Operations & Process Execution

• Execute manufacturing operations in compliance with SOP and MBR requirements, ensuring activities are completed as scheduled and all records are completed accurately and timely.
• Perform drug conjugation reactions, purification, weighing, sampling, and sample management activities.
• Operate and support equipment related to conjugation and purification processes to ensure safe and efficient manufacturing operations.

2. Equipment Qualification & Facility Support

• Participate in FAT (Factory Acceptance Testing), SAT (Site Acceptance Testing), and IOPQ (Installation, Operational, and Performance Qualification) activities.
• Support workshop and facility maintenance to ensure production equipment and facilities operate as intended and meet operational requirements.

3. Quality Compliance & Documentation

• Draft, review, and maintain SOPs and relevant process documentation according to leadership direction.
• Support activities related to deviations, change control, audits, and other quality system processes as assigned.
• Participate in and support internal and external audits and inspections, providing documentation and operational support as required.
• Utilize and maintain records within electronic systems, including MasterControl, LIMS, MDH, OneBPM, and other applicable systems.
• Act as supervisor delegate in the absence of the supervisor, ensuring continuity of operations and task coordination.
• Support team leadership to ensure smooth daily operations, including shift execution and task alignment.
• Represent the team in communication with internal and external stakeholders, ensuring alignment on operational and quality-related matters.
• Support project production readiness, including participation in project scheduling activities.
• Assist in drafting and reviewing solution lists and Bill of Materials (BOM) to ensure timely material and resource availability.

5. Other Responsibilities

• Complete other ad-hoc or interim tasks assigned by leadership to support operational and business needs.

Requirements

• Bachelor degree or above in Chemistry, Biochemistry, Biology, Pharmaceutical. Biological Engineering, or related field.
• Minimum of 1-2 years of hands‑on experience in biopharmaceutical manufacturing. Priority consideration accorded to candidates with proven senior‑level expertise in antibody manufacturing processes.
• Familiar with GMP regulatory requirements and expectations of HSA, FDA, China NMPA, EU, and ICH guidelines.
• Solid understanding of sterile pharmaceutical manufacturing processes and pharmaceutical quality systems.
• Familiar with the application of Single-Use Technologies (SUT) in biopharmaceutical manufacturing.
• Familiar with downstream processing and/or bioconjugation manufacturing processes.