Analyst à Espagne

Amgen is one of the world’s 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 (MES) in Amgen Singapore Manufacturing.

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 Amgen’s NextGen Manufacturing strategy.

• 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.

• 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 Amgen’s 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.

• 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.

• 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 Amgen’s 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.

• Doctorate degree in Computer Science, Information Systems, Engineering, or Life Sciences OR
• Master’s degree in Computer Science, Information Systems, Engineering, or Life Sciences and 2 years of directly related experience OR
• Bachelor’s 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 (PAS|X 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 PAS|X) 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.

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.

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

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.