Process Engineering Design Lead

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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.