Electronic Batch Record Specialist

AstraZeneca plc

Singapore

On-site

SGD 100,000 - 180,000

Full time

2 days ago
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Job summary

AstraZeneca plc seeks an Electronic Batch Record Specialist to design, deploy, and continually improve MES within the Manufacturing Execution System. You will collaborate with manufacturing, quality, engineering, IT, and supply teams to deliver robust, audit-ready digital batch records that scale with the pipeline.

The role emphasizes driving deviations prevention, reducing cycle times, and ensuring patient supply continuity through compliant digital solutions and effective training, with a bias

Qualifications

  • Degree in a technical or scientific field with relevant experience.
  • Demonstrated expertise in manufacturing or engineering within GXP environments.
  • Experience as recipe author / batch coordinator for MES systems such as PAS-X, Syncade, Opcenter or Pomsnet.
  • Knowledge of SHE and SOP protocols in regulated settings.
  • Hands-on experience with continuous improvement tools and methods.
  • Foundational understanding of project execution and contributing to minor projects.
  • Proven ability to communicate with diverse audiences clearly.

Responsibilities

  • Drive MES deployment and continuous improvement for safer, faster batch execution.
  • Define and maintain clear User Requirements for MES environments.
  • Coordinate stakeholders to configure MES objects on schedule.
  • Lead commissioning, validation, and audit-ready documentation for MES.
  • Create MES trainings and SOPs to enable consistent operations.
  • Provide MES user training in collaboration with the training team.
  • Manage MES content for new products and process changes.
  • Support deviations, change control, and regulatory inspections.
  • Promote digital adoption across the area and coach team members.

Skills

Degree in technical
GxP manufacturing
MES experience
SHE/SOP knowledge
CI methods
Project execution
Cross-functional comms

Education

Relevant technical/science degree

Tools

PAS-X
Syncade
Opcenter
Pomsnet

Job description

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 standards, and SOPs to maintain safe, compliant operations.
  • Communication and Reporting: Translate complex technical concepts for both technical and non-technical audiences; contribute to improvement strategies and internal reporting.
  • Digital Adoption: Embrace new digital tools and technologies; collaborate to increase digital adoption across the area.
  • Coaching and Development: Invest in personal development and support the growth of less experienced team members to build capability across the team.
Essential Skills/Experience:
  • Possess or pursuing a degree in a relevant technical or scientific discipline OR High School/Technical/Associate/Vocational diploma with equivalent experience
  • Demonstrated expertise in manufacturing or engineering processes within GXP environments
  • Possess relevant MES experience as recipe author/ batch coordinator for PAS-X/ Syncade/ Opcenter/ Pomsnet
  • Practical knowledge of SHE, and SOP protocols
  • Hands-on experience with continuous improvement strategies and tools
  • Foundational understanding of project execution and ability to contribute to minor projects
  • Proficiency in engaging diverse audiences with clear and effective communication
Desirable Skills/Experience:
  • Hold a professional qualification
  • Committed to formal technical development
  • Awareness of product supply chain concepts
  • Understanding of machinery and process performance interactions

When we put unexpected teams in the same room, we unleash bold thinking with the power to inspire life-changing medicines. In-person working gives us the platform we need to connect, work at pace and challenge perceptions. That's why we work, on average, a minimum of three days per week from the office. But that doesn't mean we're not flexible. We balance the expectation of being in the office while respecting individual flexibility. Join us in our unique and ambitious world.

Why AstraZeneca:

Here, your expertise in digital batch execution fuels real-world impact—shortening release cycles, strengthening quality, and supporting our commitment to a more sustainable future. You will work with leading technologies in a collaborative environment where unexpected teams come together to solve complex problems, from smart automation to data-driven process improvements. We value kindness alongside ambition, and we back bold ideas with the support, exposure, and investment needed to scale them. Join a team focused on delivering more medicines to patients, while contributing to our ambitions to achieve zero carbon manufacturing by 2025 and a carbon-negative value chain by 2030.

Date Posted

15-Oct-2026

Closing Date

14-Oct-2026

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

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