Specialist IS Business System Analyst (MES)

Career Category

Job Description

Specialist IS Business System Analyst (MES)

Amgen Singapore Manufacturing

HOW MIGHT YOU DEFY IMAGINATION

Amgen is one of the worlds leading independent biotechnology companies. For over 4 decades Amgen has pioneered biotechnology breakthroughs to bring state-of-the-art medicines from laboratory to the patient. Amgen has not only discovered and developed innovative human therapeutics but has invested in cutting edge manufacturing capability and support services to deliver these exciting therapies to medical teams around the world. Japan and Asia Pacific (JAPAC) is the fastest growing region in Amgen. Now we are hiring a Specialist IS Business System Analyst in Amgen Singapore Manufacturing.

Live

What you will do

Responsibilities

As part of the Digital Technology & Innovation (DTI) organization this role will serve as the primary System Owner and Subject Matter Expert (SME) for the Manufacturing Execution System (MES) at Amgen Singapore Manufacturing (ASM). The incumbent will ensure MES system reliability GMP compliance and continuous improvement to support automated biopharmaceutical manufacturing operations.

In addition to MES system leadership the candidate will play a business system analyst role partnering with cross-functional stakeholders to drive digital transformation system integration and process digitalization initiatives aligned with Amgens NextGen Manufacturing strategy.

Key Responsibilities

System Ownership and Compliance

• Serve as System Owner for MES ensuring reliability data integrity and continuous GMP compliance.
• Execute configuration and system changes under formal change control to optimize performance while maintaining validated state.
• Perform periodic system reviews including SOP audit trail access management and validation documentation updates.
• Ensure system documentation configuration records and validation deliverables remain inspection-ready at all times.
• Support internal and external audits inspections and data integrity assessments.
• Maintain alignment with global computer systems validation (CSV) and Annex 11 / 21 CFR Part 11 requirements.

Operations and Service Delivery

• Lead MES operations including incident and problem management vendor coordination and SLA performance monitoring.
• Manage system maintenance patching backup disaster recovery and business continuity in compliance with Amgens standards.
• Implement and sustain cybersecurity controls aligning with enterprise IT/OT frameworks.
• Ensure seamless integration of MES with automation systems (e.g. DeltaV PLCs SCADA) data historian (PI) and enterprise platforms (SAP IDA system).
• Support production execution recipe management and system interface stability for manufacturing operations.

Technical Expertise and Troubleshooting

• Administer and maintain MES configurations master data electronic batch records (EBR) and user management.
• Troubleshoot MES and integration issues in collaboration with cross-functional teams (Process Engineering QA Automation Global Platform).
• Provide peripheral support and troubleshooting for HMI printers scanners and scales used within MES-related manufacturing operations.
• Lead or support root cause analysis and implement corrective/preventive actions (CAPA) to ensure system reliability.
• Monitor MES performance and proactively identify opportunities to improve system efficiency and user experience.

Projects and Digital Transformation

• Lead or support MES upgrade projects new product introductions (NPI) and system enhancement initiatives.
• Participate in global NextGen MES deployment and standardization efforts ensuring site alignment with enterprise architecture and data strategy.
• Support integration of MES with advanced analytics IIoT and cloud technologies as part of Amgens digital transformation.
• Collaborate with global and site teams to design and implement scalable compliant solutions aligned with ISA-88/ISA-95 standards.
• Drive continuous improvement through process digitalization data-driven decision-making and adoption of emerging technologies.
• Act as a Business System Analyst (BSA) to translate operational needs into digital solutions that improve manufacturing performance and data flow.

Win

What we expect of you

Basic Qualifications

• Doctorate degree in in Computer Science Information Systems Engineering or Life Sciences OR
• Masters degree in Computer Science Information Systems Engineering or Life Sciences and 2 years of directly related experience OR
• Bachelors degree in Computer Science Information Systems Engineering or Life Sciences and 4 years of directly related experience OR
• Diploma and 8 years of directly related experience
• 10 years experience supporting or implementing MES (PASX or equivalent) in biotech or pharmaceutical operations.
• Strong knowledge of MES architecture configuration and integration with SAP DeltaV and data historian systems.
• Experience with system upgrades virtualization and lifecycle management.
• Understanding of data analytics IIoT and AI/ML applications in manufacturing.
• Experience working with global matrixed teams and managing vendor or project partners.
• Demonstrated ability to lead technical projects and support continuous improvement initiatives.
• Independent organized and self-motivated with a high level of integrity and compliance approach.
• Demonstrated ability to translate business requirements into technical solutions that drive operational excellence.
• Knowledge of GAMP 5 ISA-88 and ISA-95 standards.
• Experience contributing to digital manufacturing data analytics or AI/ML initiatives.
• Good understanding of GxP 21 CFR Part 11 / Annex 11 CSV and data integrity principles.
• In-depth technical knowledge of MES systems (e.g. Körber PASX) and their integration with automation and enterprise environments.
• Experience applying risk-based approaches to computer validation and system lifecycle management.
• Strong knowledge of cyber resilience and implementation of cybersecurity controls for manufacturing systems.
• Good communication and presentation skills capable of engaging with team members across all levels.
• Strong analytical solve and process improvement skills.
• Demonstrable ability to manage multiple projects and priorities in a dynamic environment.
• Collaborative approach with a focus on innovation and operational excellence.

Thrive

What you can expect of us

As we work to develop treatments that take care of others so we work to care for our teammates professional and personal growth and well-being.

• Vast opportunities to learn and move up and across our global organization
• Diverse and inclusive community of belonging where teammates are empowered to bring ideas to the table and act
• Generous Total Rewards Plan comprising health finance and wealth work/life balance and career benefits

Your selection for this role will be subject to fulfilling the medical requirements of this job scope. If so you will be informed of the medical check(s) that you may need to undergo. All medical related expenses incurred from this medical check shall be borne by the company.

Apply now

for a career that defies imagination

In our quest to serve patients above all else Amgen is the first to imagine and the last to doubt. Join us.

Equal Opportunity Statement

Amgen is an Equal Opportunity employer and will consider you without regard to your race color religion sex sexual orientation gender identity national origin protected veteran status or disability status.

We will ensure that individuals with disabilities are provided a 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 an accommodation.