Senior Process Engineer - Biopharma

• Assist the Lead Process Engineer with conceptual design deliverables such as Process Flow Diagrams, Material and Energy Balances.
• Design utilities generation and distribution systems for new and existing manufacturing processes, including Utility Sizing models.
• Generate Process P&IDs that include, process control strategy and CIP/SIP functions, if appropriate. Also, generate P&IDs for critical utility systems, such as Pharma Water systems, Clean Steam, Process Gases, Heat Transfer Systems and Process Waste.
• Perform engineering studies for expanding, improving or automating existing facilities without supervision.
• Generate/review Equipment specifications and Equipment Datasheets for process equipment and instrumentation.
• Support the delivery of Vendor packages through Scoping, Specification, Detailed Design, Construction and CQV.
• Generate Process Calculations to support design.
• Support Process Safety and Environmental studies including HAZOP, Risk Assessment.
• Ensures completion and turnover of all project origination design development, and ETOP documentation.

• Minimum of 8 years of process engineering design experience.
• Process design and operations experience in pharmaceutical facilities, which include biologic and/or organic synthesis Active Pharmaceutical Ingredients.
• Bachelor’s or master’s degree in chemical / Biochemical Engineering (or equivalent education).
• At least 4 years of experience in a GMP or highly regulated engineering environment including upstream and downstream biopharmaceutical facility design, troubleshooting, start-up and commissioning at a senior level working with clients, vendors and other design engineers to execute projects for biotech and pharmaceutical clients is an advantage.
• General knowledge of Pharma system design and applicable codes in process engineering.
• Has demonstrated strong time management skills and the ability to manage projects, problem solve and communicate effectively with co-workers.
• Good interpersonal and communication skills.
• Willing to travel for project durations.
• Takes ownership of assignments, can work both independently and as part of the team.
• Ability to work in a fast paced and challenging environment.
• Excellent organization skills with the ability to manage multiple tasks simultaneously.
• Must be able to manage and lead people effectively.

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