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Director of Engineering

Company: IBIO
Location: Bryan
Posted on: June 10, 2021

Job Description:

Director of EngineeringiBio is a global leader in plant-based biologics manufacturing. Our FastPharming System combines vertical farming, automated hydroponics, and glycan engineering technologies to rapidly deliver gram quantities of high-quality monoclonal antibodies, vaccines, bioinks and other proteins. We accomplish all of this via our CGMP 130,000 square foot facility in Bryan, TX.Just imagine what we can do together! We know great things happen when talent and opportunity cross paths. We are looking to hire exceptional people who have demonstrated track records of success. Our greatest scientific solution is bringing talented people together who have a passion for advancing plant-based biologics for our customers and the world.Apply now for our Director of Engineering position and help bring the power of plants to the biopharmaceutical industry!Mission of the PositionThe Director of Engineering leads the functions responsible for the Facility Engineering, Process Engineering & Automation, Validation, Maintenance & Calibration, and EHS ensuring a safe and functional operating environment to deliver quality products. This role will be responsible for the internal team functions as well as coordination of external suppliers supporting the organization. This position will continue to build and develop iBio's Engineering function. The Director of Engineering will be responsible for developing people, processes, equipment and facilities.Position SummaryThe Director of Engineering will provide a vision to maintain, develop and build iBio's facility assets, providing visibility and synchronizing organizational capital needs from R&D and Process Development through Manufacturing, Quality and Finance. This position will champion technology, best-in-class facilities and equipment and their implementation for organizational benefit. The Director of Engineering will be driven to develop partnerships and work across functions to deliver on commitments to build organizational value.Essential Duties & Responsibilities* Develop and implement strategies for Engineering infrastructure, processes and systems to support internal R&D laboratories and drug substance manufacturing for clinical stage biologics manufacturing and beyond* Plan and direct all aspects of engineering activities and projects to enable organizational compliance and decision making* Utilize Good Engineering Practices (GEP) and provide technical oversight and guidance for iBio's facilities and process control* Facilitate the Capital Expenditures (CapEx) and Facility Master Planning in alignment with organizational goals* Direct the user requirements, design process, and qualification activities for facility and equipment.* Be responsible for IQ/OQ/PQ and validation of facilities and manufacturing process* Direct external partners in the design and build of laboratory, office and GMP manufacturing spaces* Communicate and promote Key Performance Indicators within the Engineering functions and across organizational functions to predict and perform.* Ensuring availability of facility and equipment for internal customers and stakeholders* Implement methods/systems/tools to analyze performance of process and facilities equipment* Initiate/lead improvement events, using lean tools, that reduce waste, improve quality and enhance performance* Provide models, forecasting, options and analytics for decision making purposesKnowledge, Skills, & Abilities* Thorough understanding of Engineering systems in a cGMP environment, including, but not limited to work orders, calibration and lifecycle management, validation and change control.* Strong knowledge of biologics manufacturing equipment and utilities systems, including but not limited to HVAC, WFI, pure steam, clean compressed air, process gases, chilled water, boilers, and wastewater treatment.* Agile business leader that can navigate the organization and align cross functional teams* Demonstrated performance in building and leading high performing teams.* Demonstrates a broad understanding of clinical and commercial biopharmaceutical operations.* Possesses strength working with Building Management Systems, Equipment automation & controls.* Knowledgeable on project management principlesEducation & Experience* Bachelors' Degree in an Engineering discipline, required; graduate degree in Engineering discipline or MBA preferred* Minimum 8-10 years leading Engineering functions in the biopharmaceutical industry; clinical and commercial facility experience preferred* Experience and/or certification in Six Sigma or LEAN principles Associated topics: design, engineering, manufacture, product, product manager, production, program manager, quality

Keywords: IBIO, Bryan , Director of Engineering, Other , Bryan, Texas

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