Associate Director, Process Engineering
Takeda
Summary
Own site Process Equipment and ensure it is fit for purpose for the manufacture of drug substance and drug products, meeting Regulatory, Quality, Capacity and EHS requirements.
Job description
Objectives/Purpose
Own site Process Equipment and ensure it is fit for purpose for the manufacture of drug substance and drug products, meeting Regulatory, Quality, Capacity and EHS requirements.
Accountabilities
- Lead technology selection and evaluation of state-of-the-art process equipment and vendors (e.g. Robotics, Single Use Technology)
- Own business case development for CAPEX investments including Total Cost of Ownership calculations
- Manage Process Equipment Vendors and Architectural/Engineering firms in delivery of CAPEX and OPEX projects
- Develop Process Unit Operation Capacity models and identify capacity bottlenecks in GMP manufacturing processes
- Apply knowledge of heat transfer, mass transfer, fluid dynamics, reaction kinetics to solve process engineering problems
- Lead Front End Engineering and Design activities in feasibility and conceptual design phases
- Deliver Project Turnover Packages for Process Equipment and maintain critical engineering knowledge
- Gather requirements from stakeholders to determine Process Basis of Designs, specifications and designs
- Develop Scope of Work and RFx Packages for vendors, consultants, and contractors
- Lead commissioning activities such as Factory Acceptance and Site Acceptance Testing
- Deliver Qualification and Validation activities for Process Equipment with Engineering Validation
- Own Design Reviews of Process Equipment with Stakeholders
- Conduct Process Hazard Analysis (e.g. PHA-Hazop) and incorporate improvements into design
- Own Investigations for process equipment and implement Corrective and Preventive Actions (CAPA)
- Provide leadership of Manufacturing and Maintenance departments with troubleshooting activities
- Own continuous improvement activities applying tools such as DMAIC, FMEA, RCA
- Responsible for Management of Change for Process Equipment
- Responsible for internal and regulatory Audits and Inspections
- Engage in the Process Engineering Community of Practice
Leadership
Displays and drives Takeda culture of Takeda-ism, PTRB, safety, and quality. Coach, motivate, develop, recognize and mentor the engineering staff, including senior level engineers and managers. Strong communication skills to effectively communicate with all levels of professionals, both internal and external.
Education, Behavioural Competencies and Skills
- Engineering degree or equivalent required; Chemical, Biochemical, Mechanical or Industrial engineering preferred
- Minimum 8 years of relevant experience
- Expert of Process Unit Operations in Pharmaceutical Manufacturing
- Experience in supporting CAPEX project delivery and equipment acquisition processes
- Experience in applying process improvement methodologies such as DMAIC and Root Cause Analysis (RCA), and tools such as Failure Mode and Effects Analysis (FMEA)
- Understanding of Good Manufacturing Practices (GMP)
- Experience with leading experts for e.g. statistical data analysts and data visualization tools
- Experience owning all machines/lines/systems and all of its components
- SME of Process Unit Operations in Pharmaceutical Manufacturing
- Expert of CAPEX project delivery and equipment acquisition processes
Requirements
- Engineering degree or equivalent required
- Chemical, Biochemical, Mechanical or Industrial engineering preferred
- Minimum 8 years of relevant experience
- Expert of Process Unit Operations in Pharmaceutical Manufacturing
- Experience in supporting CAPEX project delivery and equipment acquisition processes
- Experience in applying process improvement methodologies such as DMAIC and Root Cause Analysis (RCA), and tools such as Failure Mode and Effects Analysis (FMEA)
- Understanding of Good Manufacturing Practices (GMP)
- Experience with leading experts for e.g. statistical data analysts and data visualization tools
- Experience owning all machines/lines/systems and all of its components
- SME of Process Unit Operations in Pharmaceutical Manufacturing
- Expert of CAPEX project delivery and equipment acquisition processes
- Strong skills to work in matrix organization with excellent interpersonal, communication, influencing, and negotiation skills required
Benefits
- 401(k) Matching
- Medical, Dental & Vision
- Paid Time Off
Company overview
Takeda Pharmaceutical Company Limited is a Japanese multinational pharmaceutical company founded in 1781 and incorporated in 1925. As one of the world's top 20 largest pharmaceutical companies by revenue and the third largest in Asia, Takeda specializes in developing and commercializing innovative medicines across several therapeutic areas including oncology, rare diseases, neuroscience, gastroenterology, plasma-derived therapies, and vaccines. With approximately 49,095 employees globally, the company operates research and development centers, manufacturing facilities, and commercial operations across 39 U.S. states and numerous countries worldwide. Takeda maintains dual headquarters in Tokyo and Osaka, Japan, with significant operations in Cambridge, Massachusetts, where it serves as the largest life sciences employer in the state. The company's patient-focused approach is guided by its Takeda-ism values of Integrity, Fairness, Honesty, and Perseverance, emphasizing a commitment to delivering life-transforming treatments while advancing sustainable healthcare solutions. Takeda's extensive portfolio includes both innovative biologics and small molecule drugs, supported by strategic acquisitions and partnerships that have expanded its capabilities in areas such as immuno-oncology and rare disease treatments.