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Preventative and corrective maintenance of manufacturing equipment including fermentation equipment, process vessels, purification equipment, autoclaves, component washers, and other ancillary manufacturing equipment.
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Building Management System Experience (Siemens, Johnson Controls) a plus. Owner of the Blue Mountain Calibration and Maintenance System (CAMS). The Utilities & Facilities/GMP Maintenance Manager is responsible for the corrective and preventative maintenance program at the Horsham facilities including: supervision of internal employees and contractors, administration of computerized maintenance management system and building management systems, and execution of corrective and preventative maintenance for plant utilities and GMP manufacturing equipment.
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Knowledge of yeast fermentation and metabolism. Participate in/drive fermentation and/or purification of proteins/VLPs at lab and pilot scale. Experience performing fermentation or cell culture studies at the labs scale.
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This position will report to the Technical Operations Department and will support the manufacture of HPV Gardasil as part of a multidisciplinary team, the candidate will have a fundamental knowledge of fermentation and cell culture, protein chemistry and purification, analytical techniques and/or laboratory operations.
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Supervises internal personnel in the execution of plant maintenance and calibration activities. Scheduling of plant maintenance & calibration activities and coordination of maintenance activities with area management.
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Functioning as a key member of the process development team through executing lab-scale process development, in-process assay support, and process scale-up or scale-down of cell culture/fermentation (upstream) and/or purification (downstream) process unit operations.
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Complete deviation investigations, change controls, and CAPA’s for assigned areas of responsibility. Plant Maintenance & Calibration. Develops and maintains Standard Operating Procedures for calibration and maintenance of GMP plant systems.
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