Principal Software Development Engineer
On-siteHyderabad, Telangana, India
Hyderabad, Telangana, IndiaOn-siteFull TimeSenior LevelSmall
Full TimeSenior LevelSmall
Job Summary
Lead the design, development, and optimization of Amgen's Unified Lab Management platform, focusing on end-to-end digitization of lab experimentation, simulations, and electronic recipe management. Drive architectural decisions across multiple projects while coaching mid-level and senior engineers to maintain technical excellence and scalability. Collaborate with IS Architects and stakeholders to implement integrated solutions spanning PLM, ERP, MES, and Enterprise Data Lake, ensuring seamless data harmonization and compliance with GxP standards. Manage external contractors, oversee project backlogs, and facilitate cross-functional delivery to accelerate product development and commercial manufacturing processes.
Required Qualifications
- Bachelor's Master's degree with 12 - 18 years of experience in Engineering, IT or related field
- Degree in Computer Science, Information Systems, Engineering, or Life Sciences
- 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#
- Strong database management experience with SQL RDBMS and SPARQL
- 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
- 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
- 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
- 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
- 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
Desired Qualifications
- Experience with development languages such as Java, Python, Pipeline Pilot, C# a plus
- 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
- 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
- Understanding of ITIL processes and implementation
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