Job Title: Electronic Batch Record Specialist
Career Level: C
About Singapore ADC Site:
Be part of history in the making. AstraZeneca is building its first biologics manufacturing campus in Singapore — a groundbreaking USD 1.5 billion investment that will serve as a global hub for innovation and excellence.
This innovative facility will deliver end-to-end Antibody-Drug Conjugate (ADC) capabilities with different manufacturing units/buildings in one campus:
Small molecule- chemical API production
Large molecule- monoclonal antibody manufacturing
Conjugation
Fill-and-finish operations, including sterile filling and lyophilization
Final secondary packaging
The campus will be equipped with innovative digital and automation infrastructure, enabling autonomous manufacturing powered by artificial intelligence. In addition, it will be designed for carbon neutrality, embedding sustainability into every aspect of operations and setting a new benchmark for environmentally responsible biologic's manufacturing.
In Manufacturing Team, we are looking for passionate individuals with relevant experience who thrive in dynamic environments and bring a “make-it-happen” attitude. Joining us means contributing to a project that will not only transform AstraZeneca’s global supply chain but also advance life-changing medicines for patients everywhere.
If you’re ready to help define the future of biologics and be part of a once-in-a-generation project, we want you on our team.
Introduction to role:
Are you ready to harness digital manufacturing to accelerate the delivery of life-changing medicines? In the role Electronic Batch Record Specialist, you will connect innovative Manufacturing Execution System with the shopfloor. You will turn complex processes into simple, reliable, and compliant digital execution. Your work will directly reduce batch cycle times, enhance right-first-time performance, and improve patient supply continuity.
In this role, you will own the design, deployment, and continuous improvement of Electronic Batch Records within our Manufacturing Execution System. You will partner with colleagues across manufacturing, quality, engineering, IT, and supply teams to deliver robust, audit-ready solutions that scale with our pipeline. How would you shape a digital batch record that prevents deviations before they happen?
Accountabilities:
MES Deployment and Improvement: Drive deployment, implementation, and continuous improvement of MES within manufacturing, delivering safer, faster, and more reliable execution.
User Requirement Specifications: Define and maintain clear, testable User Requirement Specifications aligned to process needs and regulatory expectations.
Cross-Functional Coordination: Coordinate stakeholders to create, configure, and test MES objects (batch records, equipment, logbooks, system interfaces) on time and to standard.
Commissioning and Validation: Lead commissioning, testing, qualification, and validation of MES objects to ensure compliant, audit-ready systems.
Documentation and Training: Create and maintain MES trainings, Standard Operating Procedures, and technical documentation that enable consistent, high-quality operations.
User Enablement: Provide effective training for MES users in partnership with the training team, ensuring adoption and sustained performance.
Object Lifecycle Management: Build and maintain MES content to support new products, expansions, evolving process requirements, and continuous improvement initiatives.
Quality Management: Drive deviation and change control activities in compliance with procedures and applicable regulations, safeguarding product quality.
Shopfloor Support: Deliver real-time troubleshooting and guidance during operations to minimize downtime and protect patient supply.
Audit Readiness: Ensure audit readiness and support regulatory inspections and certifications with accurate records and robust processes.
Compliance and Safety: Apply comprehensive knowledge of GMP, SHE…