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

• Bachelors Degree in Chemical Engineering Bioprocess Engineering Pharmaceutical Engineering or related discipline.
• Masters 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.