Process Manufacturing Engineer I
Company: Sun Pharmaceuticals, Inc
Location: Billerica
Posted on: May 3, 2021
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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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