Process Manufacturing Engineer

Company: RCM Technologies
Location: Billerica
Posted on: May 3, 2021

Job Description:

Reference # :21-00285Title :Process Manufacturing EngineerLocation :Billerica, MAPosition Type :Direct PlacementExperience Level :Start Date :04/15/2021 DescriptionPosition: Process Manufacturing EngineerCoordinate and/or implement process equipment/utilities,Perform maintenance according to current Good Manufacturing Practices (cGMPs) and following company 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 / Lyophilization 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 + Bachelor's 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, CTU's) + Familiarity with FDA cGMP, SOPs and ISO standards + Knowledge of pharmaceutical manufacturing equipment and utilities + Familiarity/Knowledge of aseptic techniques + Excellent communication skills RCM Technologies is a leading provider of IT Business Solutions and Engineering Services to over 1,000 clients in the commercial and government sectors. RCM partners with clients to define implement and manage a broad range of technologies across multiple platforms, systems, and networks. Our broad geographic presence ensures that a proven and reliable tactical and strategic capability is available and deployable virtually everywhere in North America. RCM Technologies , (USA) Inc. is an Equal Opportunity Employer M/F/D/V. RCMT encourages applicants of all ages. #Monster#CB

Keywords: RCM Technologies, Billerica , Process Manufacturing Engineer, Other , Billerica, Massachusetts