Head Digital Manufacturing Engineering Design
PharmaBiotechRegulatory AffairsQuality Assurancegmpcroinform
Job description
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job Description OBJECTIVES/PURPOSE · Lead the Digital Manufacturing function within the GCC and provide global expertise supporting digital transformation across pharmaceutical manufacturing facilities. · Build and develop organizational capability, technical expertise, leadership pipelines, and resource capacity across Manufacturing Systems, OT Integration, Data & Analytics, and Pharma 4.0 capabilities. · Drive innovation, digital engineering, smart manufacturing, and continuous improvement through data-driven and scalable digital solutions. · Ensure digital manufacturing solutions support GMP, quality, regulatory, data integrity, cybersecurity, sustainability, and business requirements. Accountabilities Functional Leadership Lead and develop Digital Manufacturing Design Leads and subject matter experts. Establish workforce planning, capability development, succession planning, and talent strategies. Support recruitment, onboarding, engagement, and retention of digital manufacturing talent. Foster a culture of innovation, collaboration, accountability, and continuous learning. Digital Manufacturing Expertise Provide global expertise for Manufacturing Systems, OT Integration, Data Platforms, Analytics, and Pharma 4.0 capabilities. Support development and adoption of digital manufacturing standards, best practices, and technology roadmaps. Enable alignment between manufacturing, engineering, automation, and digital strategies. Support technology evaluations, solution selection, and capability development initiatives. Quality, Compliance & Governance Ensure solutions align with GMP requirements, Data Integrity principles, cybersecurity requirements, and Takeda standards. Ensure compliance with GAMP5, CFR Part 11, applicable regulatory requirements, and industry best practices. Lead technical reviews, governance activities, risk assessments, and lessons learned. Support inspection readiness and compliance initiatives. Innovation, Sustainability & Continuous Improvement Drive the Digital Manufacturing innovation strategy and Pharma 4.0 roadmap. Promote AI, advanced analytics, digital twins, connected manufacturing, and smart factory capabilities. Support sustainability initiatives through data transparency, advanced monitoring, and operational insights. Identify opportunities to improve manufacturing performance, operational efficiency, quality, and engineering effectiveness. Stakeholder Management Act as the primary GCC point of contact for Digital Manufacturing capabilities. Collaborate with Engineering, Manufacturing, Automation Design, Operational Technology, Quality, and Site stakeholders. Support enterprise initiatives related to digital transformation and manufacturing modernization. Partner with project teams and sites to ensure alignment of digital manufacturing capabilities and requirements. EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: Education Bachelor's Degree in Engineering, Computer Science, Information Systems, Automation, Digital Manufacturing, or related discipline. Master's Degree preferred. Experience 15+ years of experience in Digital Manufacturing, Manufacturing Systems, Operational Technology, Industrial Automation, or related disciplines. Experience within pharmaceutical, biotechnology, plasma, or other regulated industries. Experience leading multidisciplinary technical organizations and capability-building initiatives. Experience supporting manufacturing digitalization, smart manufacturing, or Pharma 4.0 programs. Experience with GMP-regulated manufacturing environments. Behavioral Competencies Strategic leadership and organizational development. People leadership and talent management. Stakeholder engagement and influencing skills. Innovation and digital mindset. Business and operational acumen. Change leadership and continuous improvement mindset. Strong communication and decision-making capabilities. Technical Skills Digital Manufacturing and Pharma 4.0. Manufacturing Execution Systems (MES) and Electronic Batch Records (EBR). OT Architecture, Integration, and Connectivity. Manufacturing Data Platforms and Historian Technologies. Data Analytics, AI, and Digital Twin concepts. Data Integrity, Cybersecurity, and Computerized Systems Compliance. GAMP5, CFR Part 11, and applicable industry regulations. Smart Manufacturing and Connected Factory architectures. Locations IND - Bengaluru Worker Type Employee Worker Sub-Type Regular Time Type Full time
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