Associate Director, Process Engineering

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Job Description

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 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

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

• "Factory Floor" Continuous Improvement/ Trouble-shooting / System ownership

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

• • Own continuous improvement activities for Process Equipment applying continuous improvement tools such as DMAIC, FMEA, RCA, identify improvements, design and implement improvements and own level 3 troubleshooting in collaboration with "Manufacturing" & Manufacturing sciences

• • Responsible for 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/Functional (Line) Expertise

• Technology selection

• The position will be responsible for leading the development of system/equipment specifications

• Capacity modeling and Site Master Planning

• Determined basic causes and develop recommendations for corrective action, and follow-up to ensure completion of corrective action.

• Engineering and Equipment Design

• Enable capabilities to perform troubleshooting on process equipment and systems

• "Factory Floor" Continuous Improvement/ Trouble-shooting / System ownership

• Provide leadership to analyze customer service problems and design improvement suggestions / decisions. Recommend design improvements through adaptations and modifications of standard technical principles.

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 with sensitivity 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 with 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 with 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 8 years of relevant experience

• Expert of Process Unit Operations in Pharmaceutical Manufacturing

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