Associate Director, Process Engineering

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.

Work Location Requirement: This position requires working on-site five (5) days per week.

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.

• Main objectives (key services)

• • Technology selection

• • Capacity Modeling and Site Master Planning

• • Engineering and Equipment Design

• • Safety engineering design and management

• • “Factory Floor” Continuous Improvement / Troubleshooting / System ownership

• Own strategic preparation of sites for the future by introducing new process technologies such as robotics and delivering agile process engineering solutions

• Provides leadership to all engineering disciplines during the development of the project requirements, scope, design (concept, basic, and detail), timeline, and budget#

• The incumbent is responsible for improving existing equipment to minimize production downtime. Provide leadership to all process equipment related investigations

• Develop and implement strategies to ensure cost and time effective designs while ensuring innovation and adhering to user requirements while managing daily operational support

ACCOUNTABILITIES

• Technology selection

• • Drive Cross functional stakeholder management with our Partners in Manufacturing Sciences and/or Pharmaceutical Sciences. Lead the evaluation and selection of new, state-of-the-art technologies and process equipment and applicable process equipment vendors (e.g. Robotics, Single Use Technology)

• • Identify future industry trends and decide on strategies for process equipment/technologies.

• • Own business case development for CAPEX investments in process equipment incl. Total Cost of Ownership (TCO) calculations

• • Manage Process Equipment Vendors and Architectural/Engineering firms in the delivery of CAPEX and OPEX projects in areas of responsibility.

• Capacity Modeling and Site Master Planning

• • Develop Process Unit Operation Capacity models and identify capacity bottlenecks / constraints in GMP manufacturing processes / production process and in the utilities delivery systems

• • Apply knowledge of heat transfer, mass transfer, fluid dynamics, reaction kinetics to solve common process engineering problems

• Engineering and Equipment Design

• • Lead Front End Engineering and Design activities in feasibility study and conceptual design phases

• • Deliver Project Turnover Packages for Process Equipment delivered to site and ensure that critical engineering knowledge such as, as-built drawings, operating and maintenance manuals, equipment and instrument data sheets, spare parts lists are maintained, remain accurate and up to date

• • Gather requirements from Stakeholders - such as from Quality, Manufacturing, Reliability, Maintainability, Automation, and EHS – to determine Process Basis of Designs, specifications and designs for Process Equipment, Process Control Systems, Process Instrumentation and Process Safety Systems and Devices

• • Develop Scope of Work and RFx Packages for Process Equipment Vendors, Process Engineering Consultants, Architectural / Engineering services, Commissioning services and (Sub-) Contractors

• • Lead commissioning activities such as Factory Acceptance and/or Site Acceptance Testing of process equipment

• • With Partners in Engineering Validation deliver the Qualification and Validation activities for Process Equipment

• • Own Design Reviews of Process…