Process Engineering Design Lead
Takeda · Bengaluru
Job Description
OBJECTIVES/PURPOSE
· Lead the Process Design Engineering discipline within the Global Capability Center to provide high-quality engineering design support for manufacturing operations, ensuring smooth production processes, efficient delivery, and strong alignment with Takeda standards.
· Build Process Engineering capabilities, talent, and technical expertise to support routine engineering tasks, manufacturing readiness, and sustainable process improvements.
· Drive engineering excellence, lean manufacturing, continuous improvement, process safety, and practical problem solving through standardized methods and data-driven engineering practices embedded in project and design.
· Ensure manufacturing process designs, equipment, and operational support meet GMP, quality, regulatory, safety, sustainability, and business requirements.
Accountabilities
Leadership
- Lead, coach, and develop Manufacturing Process Engineers.
- Support recruitment, onboarding, succession planning, and capability development.
- Manage discipline workload, resource planning, and delivery priorities.
Engineering Delivery
- Accountable for Process Engineering deliverables across project phases, including manufacturing process support, equipment operability, and practical production readiness.
- Support projects across OSD, Biologics DS, Biologics DP, Plasma DS, and Fill-Finish facilities.
- Ensure process designs and production equipment are fit for purpose, operable, maintainable, scalable, and aligned with manufacturing requirements and basic operational principles.
- Provide guidance on tooling, fabrication, troubleshooting, and routine engineering tasks, ensuring teams apply clear work methods and step-by-step execution where appropriate.
- Coordinate interfaces with Process Architecture, Process Piping, HVAC, Utilities, CSA, Automation, Digital Factory, and CQV teams.
Quality, Compliance & Governance
- Ensure compliance with GMP requirements, Takeda standards, EHS requirements, and applicable industry regulations.
- Ensure designs align with ISPE guidance, process safety principles, risk-based design methodologies, and engineering best practices.
- Lead technical reviews, quality assurance activities, HAZOP participation, risk assessments, and lessons learned.
- Support regulatory inspections, audits, commissioning, qualification, and quality investigations as required.
Innovation, Sustainability & Continuous Improvement
- Drive standardization, modularization, and reuse of engineering solutions.
- Promote innovation, sustainability, digital engineering, and data-driven decision making.
- Identify opportunities to improve productivity, manufacturing performance, resource efficiency, sustainability, and engineering quality.
- Apply lean manufacturing, Continuous Improvement Process principles, and Six Sigma thinking to improve production efficiency, quality, and reliable execution.
- Support development and implementation of best practices, templates, and global process engineering standards.
EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS: (List the essential and desirable education and competency requirements to perform the primary responsibilities of the job. Any minimum requirements should be noted.)
Education
- Bachelor's Degree in Chemical Engineering, Bioprocess Engineering, Pharmaceutical Engineering, or related discipline.
- Master's Degree preferred.
Experience
- 10+ years of Process Engineering experience within pharmaceutical, biotechnology, plasma, or other regulated industries.
- Experience supporting OSD, Biologics DS/DP, Plasma DS, Fill-Finish, or similar manufacturing technologies.
- Experience across Concept, FEED, Detailed Design, Construction Support, Commissioning, and Qualification.
- Experience leading multidisciplinary engineering teams and project delivery.
- Experience within EPCM, engineering consultancy, or owner-side project organizations preferred.
Behavioural Competencies
- Leadership and talent development.
- Stakeholder management and collaboration.
- Strategic thinking and decision making.
- Continuous improvement mindset.
- Innovation and digital mindset.
- Strong communication and influencing skills.
Technical Skills
- Pharmaceutical manufacturing process design and process engineering.
- OSD, Biologics DS, Biologics DP, Plasma DS, and Fill-Finish manufacturing technologies.
- Process equipment design, process calculations, and technology transfer.
- Process safety, HAZOP participation, risk assessments, and hazard mitigation principles.
- Pharmaceutical and GMP facility design.
- Knowledge of GMP, ISPE Baseline Guides, process safety methodologies, and applicable industry regulations.
- Lean manufacturing, Continuous Improvement Process, and Six Sigma principles applied to pharmaceutical engineering and manufacturing support.
- Tooling, fabrication, troubleshooting, production equipment operation, and maintenance concepts relevant to manufacturing environments.
- Commissioning, Qualification, and lifecycle management principles.
- Process simulation, digital engineering, engineering data management, and innovation tools.