Specialist Mfg 1

Job Summary

The Specialist, Manufacturing – AI-Enabled Innovation (IVI) is an individual contributor within the Amgen India Capability Center (AIN), supporting the design, development, and deployment of digital and data-enabled solutions across Amgen's global manufacturing network. In the initial phase, this role supports manufacturing sites in the deployment of core capabilities, contributing to transition readiness, knowledge transfer, stabilization activities and adoption of new ways of working. In the steady state, this role operates within the Innovation Velocity Interface (IVI), contributing to the end-to-end lifecycle of innovation—from intake and requirements definition through MVP development and scaling. The Specialist brings deep domain expertise in specific manufacturing systems or processes (e.g., MES, finite scheduling, sensing, performance management) and acts as a bridge between manufacturing SMEs and technical development teams.

This role is critical in ensuring that solutions are technically sound, compliant, and aligned to real manufacturing needs, while enabling scalable and reusable digital capabilities across the manufacturing network.

Key Responsibilities

• Transition & Deployment Support (Startup Phase)
• Support deployment of Amgen's Technology and Workforce Strategy (TWFS) manufacturing capabilities at sites, including MES standardization, documentation automation, and performance management solutions
• Participate in knowledge transfer (KT), onboarding, and stabilization activities to ensure successful transition to AIN-supported capabilities
• Work with site SMEs to capture process knowledge, system requirements, and operational constraints
• Identify and escalate risks related to process gaps, system readiness, or compliance considerations
• Manufacturing Systems & Process Expertise
• Provide deep subject matter expertise in one or more manufacturing domains, such as:
• Manufacturing Execution Systems (MES / MBR design and lifecycle)
• Finite scheduling and planning systems (e.g., PP/DS, S/4HANA)
• Sensing, data integration, and digital control towers
• Performance management and KPI frameworks
• Translate manufacturing processes into structured system and data requirements
• Define guardrails and design principles to guide solution development (e.g., what can be automated, standardized, or scaled)
• Support evaluation of system impacts, dependencies, and integration requirements
• Requirements Translation & Solution Development Support
• Work closely with Sr Managers, Product Leads, and SMEs to translate business needs into detailed functional requirements
• Partner with technical teams (AI/Data, UX/UI, engineering) to ensure solutions are aligned to manufacturing realities and constraints
• Contribute to solution design, prototyping, and MVP development
• Validate that proposed solutions are fit-for-purpose, scalable, and aligned to enterprise standards
• GxP, Validation & Compliance Alignment
• Assess whether solutions require GxP controls, validation, and documentation
• Ensure requirements incorporate data integrity, auditability, and regulatory expectations
• Partner with Quality and technical SMEs to ensure compliance-by-design in all solutions
• Support preparation of validation inputs and documentation requirements where applicable
• Innovation Lifecycle Execution (IVI Model)
• Support use cases through the IVI lifecycle: intake → evaluation → MVP → pilot → scale
• Contribute to business case inputs, including feasibility, constraints, and expected benefits
• Participate in testing, user validation, and deployment activities
• Support development of solutions designed for multi-site reuse and standardization
• Stakeholder Collaboration & Integration
• Collaborate with site SMEs, manufacturing leaders, and cross-functional partners
• Act as a technical translator between manufacturing stakeholders and development teams
• Ensure clear communication of requirements, assumptions, and constraints
• Support structured engagement that balances speed of delivery with quality and compliance
  
  

Basic Qualifications

• Doctorate/Master's /Bachelor's degree and 8 - 13 years of experience.
  
  

Preferred Qualifications

• 4+ years of experience in biopharmaceutical manufacturing, manufacturing systems, or related technical roles
• Demonstrated expertise in at least one domain:
• MES / electronic batch records (e.g., Körber PAS-X or similar)
• Finite scheduling / planning systems (e.g., SAP PP/DS, S/4HANA)
• Manufacturing data systems, sensing, or digital dashboards
• Manufacturing performance management and KPI frameworks
• Strong understanding of GxP environments, validation concepts and data integrity principles
• Experience translating manufacturing processes into system or digital requirements
• Strong fluency in product management and modern delivery practices (roadmapping, prioritization, user-centered design, adoption at scale).
• Ability to work effectively with technical teams (data engineers, developers, UX/UI) without being a coder
• Strong problem-solving and analytical skills, with attention to detail and system-level thinking
• Experience supporting system implementations, process improvements, or digital initiatives
• Effective communication and collaboration skills in a cross-functional, global environment
• Ability to manage multiple priorities and contribute to fast-paced, iterative delivery models
  
  

Additional Information

• Travel: as needed to support global stakeholder engagement (limited/periodic).
• Work Style: global collaboration across time zones; strong partnering across sites, functions, and technology teams.