Head Process 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 Objective / Purpose: Lead the Process Engineering & Architecture function within the GCC and ensure delivery of high-quality engineering services supporting pharmaceutical manufacturing facilities across all modalities. Build and develop organizational capability, technical expertise, leadership pipelines, and resource capacity across Process Engineering, Process Architecture, Process Piping, and Laboratory Engineering. Drive engineering excellence, innovation, standardization, and continuous improvement through digital and data-driven engineering practices. Ensure process solutions meet GMP, quality, regulatory, safety, sustainability, and business requirements while enabling Takeda's manufacturing network strategy. Accountabilities: Functional Leadership: Lead and develop Process Engineering & Architecture Design Leads and engineering teams. Establish workforce planning, capability development, succession planning, and talent strategies. Support recruitment, onboarding, engagement, and retention of engineering talent. Foster a culture of collaboration, innovation, accountability, and continuous learning. Engineering Delivery: Accountable for overall Process Engineering & Architecture performance across all projects and programs. Ensure adequate resource capacity and effective workload balancing across disciplines. Drive consistency, scalability, and efficiency of engineering delivery. Support project execution across Concept, FEED, Detailed Design, Construction Support, Commissioning, and Qualification. Quality, Compliance & Governance: Ensure compliance with GMP requirements, Takeda standards, EHS requirements, and applicable industry regulations. Ensure engineering practices align with ISPE guidance, process safety principles, ASME BPE requirements, and engineering best practices. Oversee quality assurance, technical reviews, risk management, and lessons learned processes. Support audits, inspections, quality investigations, and regulatory readiness activities. Innovation & Continuous Improvement: Define and drive the Process Engineering & Architecture innovation and continuous improvement strategy. Promote digital engineering, process modeling, AI-enabled tools, and data-driven decision making. Drive standardization, modularization, and reuse of engineering solutions across projects. Identify opportunities to improve productivity, manufacturing performance, sustainability, and engineering quality. Stakeholder Management: Serve as the primary GCC point of contact for Process Engineering & Architecture. Collaborate with Global Design Engineering, Project Teams, Manufacturing Sites, Discipline Authorities, and external partners. Support strategic initiatives related to technology transfers, facility expansions, network optimization, and operational excellence. Education: Bachelor's Degree in Chemical Engineering, Bioprocess Engineering, Pharmaceutical Engineering, or related discipline. Master's Degree preferred. Experience: 15+ years of engineering experience within pharmaceutical, biotechnology, plasma, or other regulated industries. Significant experience across OSD, Biologics DS/DP, Plasma DS, Fill Finish, Process Piping, and/or Laboratory Engineering. Experience leading multidisciplinary engineering organizations and complex project portfolios. Experience across Concept, FEED, Detailed Design, Construction Support, Commissioning, and Qualification. Experience within EPCM, engineering consultancy, or owner-side project organizations preferred. Behavioural Competencies: Strategic leadership and organizational development. People leadership and talent management. Stakeholder engagement and influencing skills. Business and financial acumen. Change leadership and continuous improvement mindset. Innovation and digital mindset. Strong communication and decision-making capabilities. Technical Skills Pharmaceutical manufacturing process design and architecture. OSD, Biologics DS/DP, Plasma DS, and Fill Finish facility design. Process Piping, hygienic design, and ASME BPE principles. Laboratory planning and laboratory equipment integration. Process safety, risk management, and technology transfer. Knowledge of GMP, ISPE Baseline Guides, ASME BPE, process safety methodologies, and applicable industry regulations. Commissioning, Qualification, and lifecycle management principles. Digital engineering, process simulation, engineering data management, and innovation methodologies. Locations IND - Bengaluru Worker Type Employee Worker Sub-Type Regular Time Type Full time
Stand out for this role
NoxPharm tailors your CV to this job description by aligning your experience with the role requirements and terminology. Built for pharma & life sciences.
Tailor my CV now — free to trySimilar Pharma jobs
Associate, Project Management (Pharmaceutical Labeling)
Open Scientific — Hauppauge, us
Maintenance Coordinator
Open Scientific — Bohemia, us
Manufacturing Operators - Pharmaceutical
Open Scientific — Melville, us
Pharmaceutical Mechanics - Packaging, Production, Maintanence
Open Scientific — Hauppauge, us
Warehouse - Pharmaceutical
Open Scientific — Hauppauge, us
Pharmaceutical Machine Operators
Open Scientific — Hauppauge, us