Description :
General Accountability Reporting to the manufacturing manager, the incumbent is responsible for supervising the products manufacturing, planning, and maintenance of equipment, machinery, and buildings within GMP environment. Major Elements of Position Supervises and performs all aspects of manufacturing within cGMP standards as necessary. Investigates and resolves all nonconformance manufacturing issues Supports all environmental health & safety policies and procedures in collaboration with EH&S consultant. Creates and maintains SOP ' s for manufacturing and facility systems Assists Validation with developing and executing IQ/OQ/PQ ' s of utility process systems as described in Validation Master Plan. Assists in the resolution of problems detected during start-up and Installation/Operational/ Performance Qualification. Coordinates any machine shutdowns and schedules to, PM of systems, and all clean room maintenance work. Supervises any service contracts & warranty agreements. Supervises plant calibration efforts including calibration vendors for all facilities and pro duction equipment. Supervises and implements the preventative maintenance of facility equipment, systems, buildings and other related components in accordance with written and approved SOP ' s within a GMP environment. Education & Experience Required Bach elors Degree in science or engineering; Masters Degree preferable 6-8 directly related manufacturing experience Knowledge / Skills Required Strong initiative and ability to work with minimal supervision in Manufacturing. Fluency in Windows and Microsoft Office (Word, Excel, Access, PowerPoint) Mechanical aptitud General Knowledge / Skills Interpersonal Skills and teamwork attitude Communicates Openly Verbal & Written Skills Strong analytical ability Quality - is attentive to detail and accuracy Project Management Skills - ability to multi-task Planning & Organizational Skills Flexibility & Creativit In addition, the incumbent should possess or should be able to learn new technical skills as related to manufacturing and facility operation; Commissionin g of new equipment Calibration program, maintaining calibration history file Acquire new equipment for existing and new processes Controlling/monitoring electronic systems; DAS, BMS, DSX, and Hioki with auto-dialers Emergency plans Equipment nonconforma nce investigations Safe operation of equipment and process Maintenance and work order system HVAC, Boilers, USP and RO/DI water systems, Waste Treatment, Gas Distribution, Process Instrumentation Able to collaborate with outside vendors as a technical e xpert.