Engineer II- Process

Engineer II- Process
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.
Candidate will provide technical/engineering support for site manufacturing operations including but not limited to cell culture, harvest, purification, formulation, buffer / media preparation, CIP operations and process utilities to support 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, procurement, installation and start-up of systems to support capital projects.

Job Description
·       Subject Matter Expert for upstream or downstream process equipment
·       Troubleshoot complex equipment related issues and develop sound engineering solutions to address identified problems for assigned systems
·       Routinely interact with internal manufacturing, QA, MS&T, validation, and EHS personnel to ensure project and production goals are met
·       Support site reliability efforts by monitoring of key equipment performance variables and proactively identify and address issues before they cause unplanned equipment downtime
·       Engage with both internal maintenance personnel and external vendors for issue resolution
·       Perform engineering tasks for the design, procurement, fabrication and/or commissioning phases associated with standard or custom build biotech systems
·       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
·       Provide engineering support for the technology transfer of new products into existing manufacturing operations
Job Requirements
·       BS Engineering or related field
·       Minimum 3+ years’ related industry experience required, preferred 5+ years’ experience with direct process engineering experience across multiple production unit operations
·       Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) required
·       Design experience or owners experience in process systems utilized in a biopharmaceutical or vaccine manufacturing process
·       Established troubleshooting proficiency with complex, automated process systems
·       Detailed knowledge of the process for cell culture and purification
·       Clean utilities, CIP, and formulation experience a plus as well as experience with automated DCS systems such as Delta V is a plus
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