Job Description

Assist the Lead Process Engineer with conceptual design deliverables such as Process Flow Diagrams, Material and Energy Balances. Acts as a drug product technical expert to provide solutions when troubleshooting issues in drug substance freezing/thawing, formulation, filling vials/syringes/devices, lyophilisation, inspection, and transportation, for parenteral products. Design utilities generation and distribution systems for new and existing manufacturing processes, including Utility Sizing models. Generate Process PIDs that include, process control strategy and CIP/SIP functions, if appropriate. Also, generate PIDs 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. Skills and experience required: Minimum of 4-10 years of process engineering design experience. 8 years of experience in support of Drug Product (DP) processing in specific areas such as Sterile Processing, Tech Transfer or Validation. 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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