Associate IS Engineer - Clinical Trial Registry System

As an Associate IS Engineer at Amgen, you will be responsible for managing, designing and implementing information system architectures to support business needs. You will interact with business owner and teams to analyze requirements, develop architectural designs, evaluate technology solutions, perform relevant validation and ensure alignment with industry best practices and standards. Your expertise in system architecture, strong problem-solving abilities, and ability to communicate complex technical concepts will enable you to deliver robust and scalable IT solutions.

• Collaborate with business and data stakeholders to gather requirements, assess data needs, and ensure data quality, privacy, and compliance across ETL pipelines.
• Develop, monitor, and maintain CI/ CD-enabled ETL pipelines using Databricks and AWS services (S3, Glue, Lambda, EMR, etc.).
• Optimize ETL jobs for performance, scalability, cost-efficiency, and data quality using standard processes for data ingestion, transformation, and loading.
• Identify, fix, and resolve pipeline bottlenecks or failures to maintain data pipeline health.
• Maintain user documentation for data definitions, flows, lineage, and quality rules to support audit readiness and data governance.
• Ensure alignment to data governance policies and contribute to improvement initiatives around data standardization and harmonization.
• Engage in Agile/SAFe ceremonies, provide story estimates, and deliver user stories related to data platform enhancements.
• Participate in sprint planning meetings and provide estimations on technical implementation
• Work with data engineers on data quality assessment, data cleansing and data analytics.
• Share and discuss findings with team members practicing SAFe Agile delivery model.
• Automate and Optimize data pipeline and framework for easier and cost-effective development process.
• Assist in driving validation and compliance readiness by overseeing the development of validation plans, IQ/OQ/PQ protocols, and related documentation as per GXP, 21 CFR Part 11, and Annex 11 guidelines.
• Oversee user access controls, role-based privileges, and audit trail configurations to ensure system integrity and security are maintained.
• Support the change control process for the submission system by aligning with ITIL standards and ensuring traceability for all updates, patches, and configuration changes.
• Use Jira and ServiceNow for project tracking, issue resolution, and service management.

We are all different, yet we all use our unique contributions to serve patients. The professional we seek is with these qualifications.

Basic Qualifications:

• Bachelors degree and 2 to 6 years of relevant experience

Must-Have Skills:

• Ability to analyze and interpret complex data to identify and remediate issues
• Sharp learning agility, problem-solving and analytical thinking
• Scripting skills such as PowerShell or Python
• Strong knowledge of Data Lake technologies like Databricks, etc.
• Experience in MuleSoft, Python script and REST/RESTful API script development.
• Experience in Clinical system integration.
• Good written and verbal communication skills
• Experience working in agile methodology, including Product Teams and Product Development models leading Scrum teams using Jira and Confluence, and adopting Agile methodologies like Kanban and Lean for product development.
• Proficiency in designing scalable, secure, and cost-effective solutions like cost optimization using AWS Cost Explorer.
• Have stakeholder and team management skills.
• Could lead and guide multiple teams to meet business needs and goals.

Good-to-Have Skills:

• Experience with IS Security
• Experience with Agile Project Methodology
• Familiarity with cloud platforms (e.g., AWS, Azure, Google Cloud) and their IAM services.
• Knowledge of IGA principles, including role-based access control (RBAC)
• Knowledge of incident response procedures and the ability to manage security incidents related to identity management

Professional Certifications:

• Microsoft, GCP or AWS Cloud (preferred)
• Security Certification (preferred)
• Microsoft Azure Certification (preferred)

Soft Skills:

• Analytical and troubleshooting skills
• Good verbal and written communication skills
• Ability to work effectively with global, virtual teams
• High degree of initiative and self-motivation
• Ability to manage multiple priorities successfully
• Team oriented, with a focus on achieving team goals