MANUFACTURING PROCESS EXPERT (PROCESS ENGINEER)

Brief Description: The Process Engineer is a key role in the Technical Services Department within the global Manufacturing, Science and Technology Group (MS&T). The role will provide technical and scientific leadership to introduce new biologics products/process and to improve existing processes in compliance with current pharmaceuticals standards. The role will require close collaboration with all functional areas of the technical operations team including Product and Process Design, Process Automation, Facilities Engineering, Quality Controls, Quality Assurance, Supply Chain, Manufacturing and EHS. Essential Functions/Responsibilities Support technology transfer of processes into manufacturing for both internally and externally developed processes. Work cross functionally with Process Development, Manufacturing, Quality Assurance, Quality Control, Supply Chain, Project Management, Facilities, and other departments to effectively transfer and maintain processes in the facility. Work closely with manufacturing to author appropriate batch documentation and provide technical and strategic oversight associated with GMP manufacturing. Lead and/or support the compilation of process data, including communicating project status, trend identification, and delivering internal or client presentations. Evaluate existing processes and identify process or equipment improvements to advance efficiency, consistency, and competitiveness within the market. Author and review documents including batch production records, tech transfer reports, bill of materials, process descriptions, project reports, engineering specifications, and summary reports. Act as the lead for technical support of risk assessments, gap analysis, deviations, change controls, and CAPAs including determination of product or process impact, root-cause analysis, and corrective action identification. Required Knowledge, Skills, and Abilities Significant experience in pharmaceutical development and manufacturing with a strong background in both small and large molecule technologies. Extensive knowledge and experience with late-stage clinical and commercial biologics drug substance and drug product manufacturing programs, in both small and large molecule. Proven project leadership roles in process validation, PPQ, and commercial manufacturing. Proven record of accomplishment and self-directed leadership in GMP pharmaceutical or biotechnology is required. Proven experience on cell culture, purification, and solution preparation operations using disposable-based manufacturing technologies. Ability to deliver objectives on time in pressurized, fast-paced environments, whilst also meeting all compliance, quality, and cost targets. Extensive knowledge of US FDA CFRs and European EMA, including ICH guidelines, as they relate to drug substance biological manufacturing. Good interpersonal, team, and collaborative skills are required. Excellent verbal and written communication skills in English; ability to interface with all levels of the organization. Strong understanding of Environmental, Health & Safety Requirements. Strong understanding of Quality System Requirements. Foster a culture of change, innovation and self-improvement to maximize achievement of overall site goals. Required/Preferred Education and Licenses Ph.D. (or Master's) degree in relevant field such as Chemistry, Pharmaceutical Science, Biotechnology, Chemical Engineering or related field, and preferably with 10+ (15+) years in a pharmaceutical or biotechnology CMC/cGMP environment. #J-18808-Ljbffr