Principal Software Development Engineer

You will play a pivotal role in advancing digital capabilities across Process Development and Manufacturing. Leveraging state-of-the-art technologies, including Generative AI and Machine Learning, you will ensure the seamless flow of instrument data across operational business processes and applications enabling a unified data platform for robust, consistent, standardized data and analytics across the Amgen network. Additionally, you willhelp streamline the experience for Lab Scientists, Production Operators, Floor management, and Quality Assurance fostering Best-In-Class Process Innovation. 

Role Description: 

Let’s do this. Let’s change the world. In this vital role you will work as part of a Product Team focusing on Unified Lab Management (ULM) platform accelerating Amgen’s product development and commercial manufacturing working together with a dynamic team of technical product owners, business analysts, test/validation engineers, project managers and scrum masters on the design, development, management, and optimization of Amgen Operation’sElectronic Lab Notebook and Instrument Data Acquisition Platform. 

The role requires strongexpertise in ELN Applications, Enterprise Application Integration, end-to-end data and process harmonization, as well as handling the seamless integration of Lab Instrument data to various enterprise business applications. This individual will manage key vendors and partner with stakeholders orchestrating the implementation of solutions that enable next generation lab processes including simulations, machine learning and knowledge management.

They should also have experience leading and effectively working with large, diverse and globally dispersed teams within a matrixed organization. Extensive collaboration with global cross functional teams is required to ensure seamless integration and operational excellence. The ideal candidate will have a strong background in the end-to-end software development lifecycle, technical product ownership, business analysis, be a Scaled Agile practitioner, coupled with leadership and transformation experience. This role demands the ability to drive and deliver against key organizational critical initiatives, develop a collaborative environment, and deliver high-quality results in a matrixed organizational structure.

Roles & Responsibilities:

• Serves as a technical leader across multiple teams

• Coaches mid-level and senior software development engineers

• Drive architectural decisions across multiple projects

• Maintain technical excellence and scalability in products

• Design, develop, and implement IS solutions to enable end to end digitization of lab experimentation, simulations and electronic recipe management across Operations.

• Actively engage with business users to analyze business needs, identify technology solutions capture, and document design guided by best practices in Agile development.

• Collaborate with IS Architects and System Owners to implement an integrated solution across PLM, ERP, MES, and Enterprise Data Lake

• Perform hands-on development of technology solutions including configuration of commercial software as well as extensions and integrations

• Represents software development team in cross-functional leadership meetings

• Serve as lead Solution Engineer: as well as oversee external contractors and consultants

• Review project deliverables throughout development to ensure quality and traceability to requirements and adherence to all quality management plans and standards. Participate in IS quality validation reviews.

• Oversee the backlog of requirements/user stories

• Collaborate with Platform Owners, Product Owners, Service Owners, and delivery teams to ensure delivery matches commitments, acting as a critical issue point and facilitating communication when service commitments are unmet.

• Ensure overall compliance with quality and GxP in technology services, monitor emerging technologies and trends for platform growth, and ensure ongoing alignment with strategy, compliance, and regulatory requirements.

Basic Qualifications: 

• Master’s degree with 8 - 14 years of experience in Engineering, IT or related field OR 

• Bachelor’s degree with 10 - 16 years of experience in Engineering, IT or related field OR

Functional Skills:

Must-Have Skills:

• Extensive experience designing, configuring and coding software including custom development and commercial software packages using APIs, while working within an Agile Environment and contributing to ceremonies

• Experience with integration standards, including Web Services, SOAP, REST

• Skilled with object-oriented design/development and semantic web standards

• Experience with development languages such as Java, Python, Pipeline Pilot, C# a plus

• Ability to learn new software, troubleshoot and display critical thinking techniques within improvements

• Strong database management experience with SQL RDBMS and SPARQL; working with Big Data integration and Analytics a plus

• Experience integrating solutions with ERP, and MES platforms is a plus

• Good overall understanding of business, manufacturing, and laboratory systems common in the pharmaceutical industry, as well as the integration of these systems through applicable standards.

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