Specialist, Manufacturing Technologies, AI-Enabled Manufacturing Innovation (IVI)

Amgen Inc. (IR); Hyderabad; On-site; INR 3,000,000 - 7,500,000; Full time

Job summary

Amgen India Capability Center (AIN) seeks a Specialist, Manufacturing - AI-Enabled Innovation (IVI) to design, develop, and deploy digital and data-enabled solutions across Amgen's global manufacturing network. In the startup phase, this role supports site deployment and transition readiness.

The specialist brings domain expertise in MES, scheduling, sensing, and performance management, translating processes into structured requirements and collaborating with AI, UX/UI, and engineering teams to

Qualifications

• Doctorate/Master's/Bachelor's degree and 8-13 years of experience.
• Strong understanding of GxP environments and data integrity principles.
• Experience translating manufacturing processes into system or digital requirements.
• Fluency in product management and modern delivery practices.
• Ability to work with data engineers, developers, and UX/UI teams.

Responsibilities

• Transition & Deployment Support for manufacturing capabilities at sites.
• Provide deep domain expertise in MES, scheduling, sensing, or KPI frameworks.
• Translate business needs into detailed functional requirements.
• Collaborate with AI/Data, UX/UI, and engineering teams for MVP development.
• Ensure compliance-by-design and data integrity across solutions.

Skills

MES / Electronic batch records

Finite scheduling / planning

Manufacturing data systems

KPI frameworks

Product management concepts

Cross-functional collaboration

Education

Doctorate/Master's/Bachelor's degree

Tools

Körber PAS-X

SAP PP/DS

S/4HANA

Job description

Career Category Manufacturing Job Description 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

1. 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 escalation risks related to process gaps, system readiness, or compliance considerations
2. 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
3. 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
4. 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
5. 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
6. 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

Travel

Travel: as needed to support global stakeholder engagement (limited/periodic).

Work Style

Work Style: global collaboration across time zones; strong partnering across sites, functions, and technology teams.

Amgen is committed to unlocking the potential of biology for patients suffering from serious illnesses by discovering, developing, manufacturing and delivering innovative human therapeutics. This approach begins by using tools like advanced human genetics to unravel the complexities of disease and understand the fundamentals of human biology. Amgen focuses on areas of high unmet medical need and leverages its biologics manufacturing expertise to strive for solutions that improve health outcomes and dramatically improve people's lives. A biotechnology pioneer since 1980, Amgen has grown to be one of the world's leading independent biotechnology companies, has reached millions of patients around the world and is developing a pipeline of medicines with breakaway potential. For more information, visit www.amgen.com and follow us on www.twitter.com/amgen