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 will help 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’s Electronic Lab Notebook and Instrument Data Acquisition Platform.  

The role requires strong expertise 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. 

• Understanding computer system validation and SDLC in biotech manufacturing and laboratory areas. 

• Excellent verbal, written, and interpersonal communication skills, including the ability to set the context and present sophisticated subjects to senior management in a clear and concise manner. 

• Experience building productive resourceful working relationships with business clients 

• Strong leadership, project management skills. 

• Proven leadership skills with the ability to lead large matrixed teams. In addition, demonstrated experience in leading and developing a hard-working team of technology professionals, building a culture of innovation and continuous improvement within the team to deliver powerful solutions and platform improvements. 

• Experience in implementing a strategic roadmap and driving transformation initiatives using Scaled Agile methodology. 

• Strong skills in collaborating and communicating with cross-functional teams, business collaborators, and executives to ensure alignment of platform initiatives with business outcomes, handling expectations, and ensuring successful delivery of projects. 

Preferred Skills: 

• Solid depth or breadth of expertise with offerings within the Lab solution landscape – including ELN, inventory management, MES and scientific analysis tools  

• At least 5 – 8 years of domain knowledge in health and/or life sciences combined with Information Technology 

• Understanding and applied experience in Lab Informatics and cross functional data harmonization  

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

• Up-to-date knowledge of vendor’s software strategy, information of available competing solutions and the ability to translate these to the changing business environment in PD such that we can continually maximize software investments.   

• Experience managing a globally distributed enterprise application platform  

• Leadership experience within a highly regulated pharmaceutical or technology organization, with the ability to ensure compliance with industry regulations and standard methodologies for GxP software validation. 

• Experience directing solution design, business processes redesign and software implementation in a drug development lab / commercialization environment  

• Understanding of FDA regulations governing computer system validation and operation in biotech manufacturing and laboratory areas 

• Strong analytic/critical-thinking and decision-making abilities. 

• Demonstrated ability to work effectively in a fast-paced, dynamic environment. 

• Extensive experience in the software development lifecycle. 

• Experience using and adoption of Scaled Agile Framework (SAFe) 

• Understanding of ITIL processes and implementation. 

• Established business partnerships and IS governance practices involving senior business stakeholders 

• Experience handling vendor relationships and working with external partners or consultants to ensure optimal performance, support, and development of digital products. 

Soft Skills: 

• Excellent leadership and team management skills. 

• Strong transformation and change management experience. 

• Ability to work effectively with global, virtual teams.  

• Excellent analytical and troubleshooting skills.  

• Ability to manage multiple priorities successfully. 

• Strong presentation and public speaking skills. 

• Strong verbal and written communication skills. 

• High degree of initiative and self-motivation.