Associate Director, Process Engineering

About the role

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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.
• 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
• 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

Technical/Functional (Line) Expertise

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

Takeda Compensation and Benefits Summary

• We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
• For Location: USA - GA - Social Circle - Hwy 278

U.S. Base Salary Range

$154,400.00 - $242,550.00

The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained, certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.