CMC digital domain software engineer

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need.

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

* Purpose and Scope:

For the contribution of people’s health, we are looking for a CMC Digital Domain Software Engineer to design, build, integrate, and continuously improve digital solutions and data capabilities supporting CMC research, development, technology transfer, and manufacturing.

This role will work closely with CMC business functions, Digital/Technology teams, product managers, architects, and external partners to translate business and scientific needs into reliable, scalable, and maintainable digital solutions.

The role will contribute to the implementation and integration of CMC platforms and data capabilities, including PLM/PIMS, ELN, Veeva Vault, Databricks, analytics solutions, and AI-enabled applications. The engineer will have a strong focus on system and data integration, software engineering, data engineering, technical configuration, testing, deployment, issue resolution, and lifecycle management.

The position will work as part of a global CMC Digital organization, collaborating with stakeholders across regions and functions.

* Responsibilities and Accountabilities:

• Design, develop, configure, integrate, test, deploy, and maintain CMC digital solutions and data capabilities.
• Translate functional and business requirements into technical requirements, solution designs, integration specifications, and implementation approaches.
• Implement and enhance CMC platforms and solutions such as PLM/PIMS, ELN, Veeva Vault, and related life-science applications.
• Design and implement data integration between CMC source systems, laboratory systems, enterprise applications, and data platforms such as Databricks.
• Develop and maintain APIs, ETL/ELT processes, data pipelines, interfaces, and reusable integration components.
• Support development of structured and reusable CMC data through data models, metadata, data-quality controls, lineage, and appropriate access-control mechanisms.
• Develop or support analytics applications and dashboards using technologies such as Power BI.
• Participate in the technical evaluation and implementation of emerging technologies, including Generative AI, RAG, AI Agents, and AI-enabled applications.
• Perform technical analysis and troubleshooting of application, integration, data, performance, and environment issues and implement appropriate solutions or workarounds.
• Develop and maintain technical documentation, including solution designs, interface specifications, configuration documentation, test evidence, and operational documentation.
• Apply software engineering practices including version control, code review, automated testing, CI/CD, monitoring, and release management, where applicable.
• Support technical delivery across the solution lifecycle from PoC and pilot through production deployment, operation, enhancement, and scale-up.
• Collaborate with enterprise architects, data engineers, platform teams, cybersecurity teams, and external vendors to ensure technical solutions align with enterprise standards.
• Support computerized system lifecycle, validation, security, data integrity, and compliance activities where applicable.
• Work closely with CMC users and Digital Product Managers to continuously improve digital solutions based on user needs, technical performance, and evolving business requirements.
• Collaborate with global Digital/Technology teams to develop reusable engineering patterns, common components, and scalable solutions across CMC functions and locations.

* Required Qualifications:

• Bachelor’s degree or equivalent experience in Computer Science, Software Engineering, Information Technology, Data Engineering, or a related technical field.
• Strong knowledge of software engineering fundamentals, including application architecture, APIs, databases, integration patterns, testing, and software lifecycle management.
• Hands-on experience in software development, system integration, data engineering, or enterprise application implementation.
• Good knowledge of relational databases, data models, SQL, and data integration concepts.
• Experience working with REST APIs, system interfaces, ETL/ELT, or data pipelines.
• Understanding of cloud-based solution architectures and modern application/data platforms.
• Experience translating business or functional requirements into technical designs and implementable solutions.
• Ability to troubleshoot complex application, integration, and data issues, identify root causes, and implement effective solutions.
• Understanding of software engineering practices such as source control, testing, CI/CD, release management, logging, and monitoring.
• Strong analytical and problem-solving skills.
• Ability to work effectively in Agile, cross-functional, and globally distributed teams.
• Strong collaboration skills to work with business users, product managers, architects, engineers, cybersecurity teams, and external vendors.
• Ability and willingness to continuously learn new technologies and apply them to evolving business needs.
• Professional-level English communication skills suitable for working with global teams.

* Preferred Qualifications:

Experience with Databricks and Microsoft Azure or comparable cloud/data platforms.

• Experience with programming languages commonly used for enterprise or data solutions, particularly Python and/or SQL.
• Experience implementing or integrating life-science or manufacturing applications such as ELN, LIMS, MES, PLM/PIMS, Veeva Vault, or SAP.
• Experience designing and developing APIs, microservices, integration services, ETL/ELT pipelines, or event-based integrations.
• Experience with data engineering technologies and concepts, including data ingestion, transformation, data quality, metadata, lineage, and data products.
• Experience developing analytics solutions using Power BI or similar technologies.
• Experience with Git-based development, CI/CD, automated testing, and DevOps practices.
• Experience with cloud-native application development and deployment.
• Experience developing or integrating solutions using Generative AI, RAG, LLM APIs, AI Agents, or other AI technologies.
• Knowledge of GxP, CSV/CSA, Data Integrity, cybersecurity, and regulated computerized-system lifecycle practices in the pharmaceutical or life-science industry.
• Experience working in pharmaceutical CMC, R&D, laboratory, manufacturing, quality, or technology-transfer environments.
• Experience working with global engineering teams and external technology vendors.
• Experience working in Agile software/product development teams.
• Relevant certifications in technologies such as Microsoft Azure, Databricks, software development, data engineering, security, or DevOps.