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 supportACCOUNTABILITIES 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…