Engineer II - Process (Inspection/Packaging)

 
Engineer II, Process (Inspection/Packaging)
 
PharmEng Technology is currently seeking a Process Engineer for a project in Raleigh/Durham, NC.  The position is available immediately conditional of a successful interview.
 
The engineer will provide engineering support for a high-speed syringe filling line or automated inspection and packaging equipment, for on-going commercial manufacturing operations. Responsibilities will include equipment/process troubleshooting as well as ongoing performance analysis to improve overall equipment reliability. Additional responsibilities will include design, vendor alignment, installation and start-up of additional filling and packaging equipment as part of current and future expansion projects.


Job Description
·       Subject Matter Expert (SME) for filling or inspection and packaging operations
·       Interact with internal manufacturing, QA, MS&T, validation, and EHS personnel to achieve project and production goals
·       Hands-on troubleshooting of complex high-speed filling and packaging equipment; develop sound engineering solutions to address identified problems
·       Recommend and implement performance and reliability improvements for inspection and packaging equipment
·       Engage with both internal maintenance personnel and external vendors for issue resolution
·       Independently lead small engineering projects
·       Initiate and own change controls for equipment modifications
·       Equipment lead for (DR) investigations to adequately identify root cause and implement appropriate corrective and preventative actions (CAPAs) to prevent reoccurrence.
·       Lead for the execution of start-up and commissioning activities for minor and major equipment upgrades
·       Participate in site audits by health authorities or other regulatory agencies (e.g. OSHA)
·       Provide engineering support for the technology transfer of new products into existing manufacturing operations

Job Requirements
·       BS Engineering or related field
·       Minimum 4+ years related industry experience required
·       2+ year(s) experience in pharmaceutical/biotech operations working with highly automated filling or inspection and packaging equipment
·       Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) preferred
·       Design experience or owners experience in sterile filling process equipment or highly automated high-speed inspection and packaging equipment
 
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