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 solutionsParticipate in knowledge transfer (KT), onboarding, and stabilization activities to ensure successful transition to AIN-supported capabilitiesWork with site SMEs to capture process knowledge, system requirements, and operational constraintsIdentify and escalate risks related to process gaps, system readiness, or compliance considerations Manufacturing Systems & Process ExpertiseProvide 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 towersPerformance management and KPI frameworksTranslate manufacturing processes into structured system and data requirementsDefine 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 SupportWork closely with Sr Managers, Product Leads, and SMEs to translate business needs into detailed functional requirementsPartner with technical teams (AI/Data, UX/UI, engineering) to ensure solutions are aligned to manufacturing realities and constraintsContribute to solution design, prototyping, and MVP developmentValidate that proposed solutions are fit-for-purpose, scalable, and aligned to enterprise standards GxP, Validation & Compliance AlignmentAssess whether solutions require GxP controls, validation, and documentationEnsure requirements incorporate data integrity, auditability, and regulatory expectationsPartner with Quality and technical SMEs to ensure compliance-by-design in all solutionsSupport 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 → scaleContribute to business case inputs, including feasibility, constraints, and expected benefitsParticipate in testing, user validation, and deployment activitiesSupport development of solutions designed for multi-site reuse and standardization Stakeholder Collaboration & IntegrationCollaborate with site SMEs, manufacturing leaders, and cross-functional partnersAct as a technical translator between manufacturing stakeholders and development teamsEnsure clear communication of requirements, assumptions, and constraintsSupport 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 rolesDemonstrated 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 dashboardsManufacturing performance management and KPI frameworksStrong understanding of GxP environments, validation concepts and data integrity principlesExperience translating manufacturing processes into system or digital requirementsStrong 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 coderStrong problem-solving and analytical skills, with attention to detail and system-level thinkingExperience supporting system implementations, process improvements, or digital initiativesEffective communication and collaboration skills in a cross-functional, global environmentAbility 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.