Associate Director, Process Engineering

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Job Description

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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.

• 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, Man...

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