Electronic Batch Record Specialist

About the role

AstraZeneca is building its first biologics manufacturing campus in Singapore, a USD 1.5 billion investment covering small-molecule API production, monoclonal antibody manufacturing, conjugation, sterile filling and lyophilization, and final secondary packaging. The Electronic Batch Record Specialist connects the Manufacturing Execution System with the shopfloor, turning complex processes into simple, reliable and compliant digital execution. The role owns the design, deployment and continuous improvement of electronic batch records and works with manufacturing, quality, engineering, IT and supply teams.

Key responsibilities

• Drive deployment, implementation and continuous improvement of the MES within manufacturing
• Define and maintain user requirement specifications aligned to process needs and regulatory expectations
• Coordinate stakeholders to create, configure and test MES objects such as batch records, equipment, logbooks and system interfaces
• Lead commissioning, testing, qualification and validation of MES objects
• Create and maintain MES training, standard operating procedures and technical documentation
• Provide training for MES users and build and maintain MES content for new products and process changes
• Drive deviation and change control activities in compliance with procedures and regulations
• Support real-time troubleshooting on the shopfloor and ensure audit readiness for regulatory inspections
• Apply GMP, SHE standards and SOPs, communicate technical concepts clearly and coach less experienced team members

Required profile

• Degree in a relevant technical or scientific discipline, or a high school/technical/vocational diploma with equivalent experience
• Expertise in manufacturing or engineering processes within GXP environments
• Relevant MES experience as recipe author or batch coordinator
• Hands-on experience with continuous improvement strategies and tools
• Ability to engage diverse audiences and contribute to minor projects

Required skills

• MES experience with recipe author/batch coordinator roles on PAS-X, Syncade, Opcenter or Pomsnet
• Practical knowledge of SHE and SOP protocols
• Desirable: professional qualification, product supply chain awareness and understanding of machinery and process performance interactions

The role involves an average of at least three days per week in the office, with flexibility. AstraZeneca is an equal opportunity employer.