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Professional Services - Engineer

Indianapolis, IN

Order: 109146
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Director of Engineering Pro Talent Group, a division of MS-IL Staffing & Packaging, and its local client are NOW HIRING a full-time Director of Engineering in the Indianapolis, Indiana, area! Our client is an Indianapolis based dynamic biotechnology company headquartered in CA. The company is focused on improving survival of people with cancer. As the Director of Engineering, you'll lead a team of Process, Manufacturing, Radiopharmaceutical, and Validation Engineers, contributing to the delivery of innovative drug products to patients. Manage daily operations, provide direction to your team, and support various departments through innovation to commercialization phases. Monitor budgets, ensure compliance with cGMP and radiation safety, reporting directly to the Sr. Director – Operations. Job Responsibilities Troubleshoot complex manufacturing equipment and processes, offering technical guidance to team members. Plan and manage departmental budgets. Troubleshoot complex manufacturing processes. Support Tech Transfer of new products from R&D through Commercialization. Support Process, Project, and Validation Engineers in executing their job duties. Assist internal customers with specifying, purchasing, and installing equipment for manufacturing, laboratory, development, and testing operations. Design, optimize, and troubleshoot new processes and improve existing ones. Support process improvements, both internally and cross-functionally. Initiate and/or support investigations of quality events (Deviations, CAPA, Change Control, OOS, etc.). Coordinate with external vendors, partners, and service providers. Identify and ensure stocking of critical spare parts for the support of production operations. Ensure Engineering personnel comply with site EHS and Radiation Safety programs and promote a culture of safety. Author and/or revise technical documents (SOPs, URS’s, forms, etc.) as needed. Education and Experience: 10+ years’ engineering experience in an Aseptic, cGMP Radiopharmaceutical environment is required. BS/MS Engineering Degree 6+ years proven experience in a leadership/management role. Skills Required: Strong knowledge of cGMP and aseptic practices. Strong knowledge of injectable radiopharmaceutical drug product manufacturing. Strong knowledge of Preventative Maintenance and Calibration program principles. Excellent professional ethics, integrity, and ability to maintain confidential information. Organized and detail oriented. Strong interpersonal communication skills. Motivated, adaptable, and able to work under pressure.