Manufacturing Production 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 antibodies, conjugation, sterile filling and secondary packaging. The Manufacturing Production 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, Validation, Supply Chain and EHS.

Key responsibilities

• Own assigned equipment through its lifecycle: installation, qualification and maintenance in a GMP-ready state.
• Plan and support FAT, SAT, commissioning, qualification, validation and handover, and prepare and implement 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 safety oversight.
• Represent Manufacturing in new product introductions, PPQs and campaigns, and lead single-use system lifecycle and inventory.
• Drive root cause analysis, Lean problem solving and reliability improvements.

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 GMP documentation experience.
• Comfortable in a start-up or evolving manufacturing environment, with strong collaboration across Production, Engineering, Validation, QA and EHS.

Required skills

• Equipment qualification and validation (FAT, SAT, IQ, OQ, PQ)
• GMP documentation, deviation management, change control and CAPA
• Desirable: ADC, aseptic filling, high-containment experience, single-use systems, Lean Six Sigma, EU GMP Annex 15, and willingness to travel to vendor sites