Principal Software Development Engineer

Career Category Information Systems Job Description Join Amgen’s Mission of Serving Patients At Amgen, if you feel like you’re part of something bigger, it’s because you are. Our shared mission—to serve patients living with serious illnesses—drives all that we do. Since 1980, we’ve helped pioneer the world of biotech in our fight against the world’s toughest diseases. With our focus on four therapeutic areas –Oncology, Inflammation, General Medicine, and Rare Disease– we reach millions of patients each year. As a member of the Amgen team, you’ll help make a lasting impact on the lives of patients as we research, manufacture, and deliver innovative medicines to help people live longer, fuller happier lives. Our award-winning culture is collaborative, innovative, and science based. If you have a passion for challenges and the opportunities that lay within them, you’ll thrive as part of the Amgen team. Join us and transform the lives of patients while transforming your career. 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 t he 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 streamlin e the experience for Lab Scientists, P roduction O perators, F loor 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 engin eers, project managers an d 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 , E nterprise A pplication I ntegration, 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. E xtensive 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:   Ex tensive ex perience 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.   What you can expect of us As we work to develop treatments that take care of others, we also work to care for your professional and personal growth and well-being. From our competitive benefits to our collaborative culture, we’ll support your journey every step of the way. In addition to the base salary, Amgen offers competitive and comprehensive Total Rewards Plans that are aligned with local industry standards. Apply now and make a lasting impact with the Amgen team. careers.amgen.com As an organization dedicated to improving the quality of life for people around the world, Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients. Together, we compete in the fight against serious disease. Amgen is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or any other basis protected by applicable law. We will ensure that individuals with disabilities are provided 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 accommodation. .