Manufacturing Specialist – Singapore ADC Campus

About the role

AstraZeneca is building its first biologics manufacturing campus in Singapore, a USD 1.5 billion investment covering ADC, small-molecule API, monoclonal antibody, conjugation, aseptic filling and secondary packaging. The Manufacturing Specialist joins one of the five manufacturing units (API, mAb Drug Substance, Conjugation, Aseptic Filling or Secondary Packaging) and provides technical expertise and shopfloor leadership from project execution through qualification to commercial operations, working with Engineering, Quality, MSAT, Validation, Supply Chain and EHS.

Key responsibilities

• Own the assigned equipment lifecycle: installation, qualification and maintenance in a GMP-ready state.
• Plan and support FAT, SAT, commissioning, qualification, validation and handover, and prepare and review protocols and technical documentation.
• Act as primary contact for equipment issues, troubleshooting, performance monitoring and breakdown investigations.
• Drive SOP development, batch record inputs, equipment setup, line readiness, material flow reviews and operator training.
• Keep DCS recipes aligned with MES master batch records and documentation audit-ready.
• Support risk assessments, deviations, CAPAs, change controls and corrective actions.
• Represent Manufacturing in new product introductions, readiness for PPQs and OEE improvement.
• Lead lifecycle, standardization and inventory of single-use systems and consumables.
• Drive root cause analysis, lessons learned and Lean problem solving to improve reliability and right-first-time performance.

Required profile

• Bachelor's degree in Engineering, Chemical, Mechanical, Pharmaceutical or Biotechnology engineering or a related field.
• At least 5 years of pharma/biopharma GMP manufacturing experience with hands-on equipment and production support.
• Strong equipment troubleshooting, fault diagnosis and issue resolution in a GMP environment.
• Experience supporting equipment qualification and validation (FAT, SAT, IQ, OQ, PQ).
• Good understanding of GMP documentation, deviation management, change control, CAPA and equipment lifecycle.
• Comfortable in a start-up or evolving manufacturing environment and able to collaborate across Production, Engineering, Validation, QA and EHS.

Required skills

• Desirable: start-up of a new facility, line or equipment platform.
• Desirable: ADC, high-containment, high-potency, aseptic filling or large-molecule manufacturing.
• Desirable: containment technologies, cleaning validation, manufacturing investigations, technical transfer, Lean Six Sigma.
• Desirable: familiarity with Singapore regulatory requirements and EU GMP Annex 15.
• Willingness to travel to vendor sites for qualification or project support.