Process Engineering, Director or Associate Director, Japan New Plasma Facility Project

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Job Description

ABOUT TAKEDA

OBJECTIVES/PURPOSE

• Own Process Equipment 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 and 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 e.g. Sciences and/or Pharmaceutical Sciences. Sponsor 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

  • Mentoring of 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

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

  • Sponsor Project Turnover Packages for Process Equipment are delivered to site and 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 decide on Process Basis of Designs, specifications and designs for Process Equipment, Process Control Systems, Process Instrumentation and Process Safety Systems and Devices

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

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

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

  • SME Design Reviews of Process Equipment with Stakeholders, including Quality, Manufacturing, Utilities Operations, Maintenance, Calibration, Reliability, Automation

• Safety engineering design and management

  • Conduct Process Hazard Analysis (e.g. PHA-Hazop) of hazardous manufacturing / production processes and incorporate improvements into the design of process equipment, process control, and process safety systems

  • Perform Design Reviews of all process equipment with relation to EHS and lead for the relevant changes

  • Own Investigations for process equipment and implement Corrective and Preventive Actions (CAPA)

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

  • Provide leadership the Manufacturing and Maintenance departments with troubleshooting activities of Process Equipment on the factory floor

  • Owner continuous improvement activities for Process Equipment applying continuous improvement tools such as DMAIC, FMEA, RCA, identify improvements, design and implement improvements and sponsor 3rd level troubleshooting in collaboration with “Manufacturing” &” Manufacturing sciences”

  • Mentor Management of Change for Process Equipment in area of responsibility

  • Responsible for internal and regulatory Audits and Inspections

  • Engage in the Process Engineering Community of Practice (CoP) through sharing of best practices and lessons learned

DIMENSIONS AND ASPECTS

Technical Expertise:

• Lead and mentor system/equipment specifications

• Determine basic causes, and develop and then follow up on recommendations for corrective actions

• Enable capabilities to perform troubleshooting on system/equipment

• Lead customer service problems and recommend design improvements

Leadership:

• Displays and drives Takeda culture of Takeda-ism, PTRB, safety, and quality into the organization

• Be on the floor to study and train and recommend techniques to enable the team to improve existing equipment to minimize production downtime.

• Good interpersonal skills and be able to work effectively and efficiently in a team environment as leader, mentor, trusted advisor.

• Demonstrates strong communication skills to effectively communicate with all levels of professionals, both internal (local & global) and external

• Coach, motivate, develop, recognize and mentor the engineering staff, including senior level engineers and managers. Being a mentor developing future leaders

Decision-making and Autonomy:

• Decision making on organizational changes to build the required capacity/capabilities

• Autonomy in decision making to the level of required alignment

• Decision making of short/mid & long-term impacts

Interaction:

• CAPEX Project Teams, Manufacturing Sciences, Quality, Manufacturing / Production, Utilities/Facilities Operations, Plant/Facilities/Utilities Engineering, Reliability Engineering, Maintenance, Calibration, Automation, EHS, Procurement / Purchasing, Equipment Vendors, Architectural / Engineering Services Companies, (Sub-) Contractors, Consultants

Innovation:

• Generate innovative solutions to highly complex problems

• Demonstrated problem solving skills to support resolution of Engineering, Manufacturing and/or Quality-related issues

Complexity:

• Assess, analyze, advise, propose and direct improvements that will deliver greater productivity, capacity, reliability and compliance for the Process Engineering Department

• Ensure compliance to all regulatory GMP, Safety and Environmental requirements

• Shall interface with regulatory agency representative (e.g. FDA/EMA) as the site Process Engineering SME during internal and external audits and shall be able to defend current practices to such agencies

• Strong skills to work in matrix organization with excellent interpersonal, communication, influencing, and negotiation skills required

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS

• Engineering degree or equivalent required; for example, Chemical, Biochemical, Mechanical or Industrial engineering is preferred

• Minimum 5 years of relevant experience

• Expert of Process Unit Operations in Pharmaceutical Manufacturing

• Leader of CAPEX project delivery and equipment acquisition processes

• Mentor 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 expert for e.g  statistical data analysts and data visualization tools

• Experience in managing of all machines/lines/systems and all its components

• SME of Process Unit Operations in Pharmaceutical Manufacturing

• Expert of CAPEX project delivery and equipment acquisition processes

• Fluency in English

• Fluency in Japanese is preferred

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