Associate Director, Process Engineering Social Circle, GA Category: Manufacturing Engineering

Job description

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I further attest that all information I submit in my employment application is true to the best of my knowledge. 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,