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Process Manufacturing Engineer I

Company: Sun Pharmaceuticals, Inc
Location: Billerica
Posted on: May 3, 2021

Job Description:

Process Manufacturing Engineer ILocationMA, BillericaJob CategoryEngineeringEmployment DurationFull timeCoordinate and/or implement process equipment/utilities maintenance and maintenance according to current Good Manufacturing Practices (cGMPs) and following Standard Operating Procedures (SOPs). Responsibilities + Responsible for maintenance and operation of process equipment as well as associated documentation + Support execution of preventative maintenance of pharmaceutical process equipment and utilities + Ensure that the equipment is prepared to support the production schedule and is in proper condition/calibration + Provide 24/7 operational coverage for manufacturing equipment and utilities + Support production personnel on equipment and utility operation + Support PM re-qualification of process equipment, testing & certifications of manufacturing process + Support area manufacturing and new product/process transfer activities + Follow up on equipment/utility related CAPAs, Deviations, and Investigations + Review process utilities and equipment logs + Oversee loading / lyophylization cycle and coordination of equipment + Troubleshoot and remediate exceptions found during FAT/SAT/IQ/OQ/PQ + Ensure timely closure of equipment/utility related CAPAs and/or Change Controls + Support Validation of equipment/utilities/process transfers and re-qualifications + Support URS/FS/DS engineering documents of process related systems + Other duties as assigned Qualifications + Minimum 2+ years related experience preferred + Bachelors in Science, Engineering or related field preferred or equivalent experience + Ability to oversee cGMP validation compliance efforts + Ability to operate and maintain process equipment and utilizes (Sterilizers, Depyrogenation Ovens, Lyophilers, Incubators, CTUs) + Familiarity with FDA cGMP, SOPs and ISO standards + Knowledge of pharmaceutical manufacturing equipment and utilities + Familiarity/Knowledge of aseptic techniques + Excellent organizational skills

Keywords: Sun Pharmaceuticals, Inc, Billerica , Process Manufacturing Engineer I, Other , Billerica, Massachusetts

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