Job Description

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In this role, you will be responsible for designing and implementing manufacturing processes and supporting utilities on a scale that can range from developmental pilot plants to full commercial production. Ideally, the candidate has process design and operations experience in pharmaceutical facilities, which includes biologic and organic synthesis of Active Pharmaceutical Ingredients and oral and parenteral Drug Products.

Position Responsibilities

• Coordinates with project managers to determine project scope, complexity, and schedule for project development.

• Develops project execution plans (budget, milestones, deliverables, and staffing plans) to deliver projects on time, on budget, and of the highest quality.

• Assists clients with strategic evaluations to develop concepts supported by engineering studies for expanding, improving, or automating existing facilities.

• Writes scope of work for process, utilities, and manufacturing controls based on preliminary reviews with the client.

• Completes design deliverables for single unit operations through the entire facility flow including, Process Flow Diagrams (PFD), Material and Energy Balances, utility requirements, and Process P&IDs that include controls strategy and CIP/SIP functions, if appropriate.

• Completes design for utilities generation and distribution systems.

• Generates P&IDs for critical utility systems, such as WFI, USP Purified Water, Clean Steam, and Process Gases.

• Ensures completion of quality specifications and performance data sheets for process equipment and instrumentation.

• Makes use of and participates in the development of company design tools including process simulation and smart P&IDs (AutoCAD, Plant 3D, SuperPro, etc.).

• Establishes and maintains excellent working relationships with clients and members of the IPS design team.

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