Site Engineering, Process Engineer II - North Charleston
4 weeks ago
+The Process Engineer Sterile II for our parenteral site in Charleston SC is accountable for driving results in a fast paced environment by providing technical support for the manufacturing facility including troubleshooting equipment validated processes process deviations and investigations transfers of new processes and technologies into the site and preparation of documentation to support validation and process transfer activities.
+Provides technical assistance for process transfer and validation efforts for assigned manufacturing areas Analyzes existing processes identifies areas for improvement implements changes to enhance efficiency reduce costs and improve product quality Develops new or modified processes equipment layouts to meet specific production goals Composes process validation cleaning validation or process optimization protocols Identifies specific parameters sampling tests used in the validation protocols of new existing products Writes validation technical improvement reports Monitors manufacturing processes during production runs to assess any technical process issues Assists technicians in performing physical testing during the aseptic manufacturing operation e.g sterilization depyrogenation lyophilization sanitization Participate in investigations complete CAPA assignments Utilizes FMEA to trouble shoot processing issues Participates in Capital Project planning process identifying requirements project scope documentation review other engineering design documentation Ensures timely completion compliance with cGMP all other relevant company training requirements Other duties as assigned.
Job description
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