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Job: Engineer II/III, Process (Downstream Purification), Seqirus, Holly Springs, NC
Engineer II/III, Process (Downstream Purification)
Holly Springs, NC 27540 United States
Seqirus is seeking a process engineer who 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.
Subject Matter Expert (SME) for upstream or downstream process equipment
Troubleshoots complex equipment related issues and develops sound engineering solutions to address identified problems for assigned systems
Routinely interact with internal manufacturing, QA, MS&T, validation, and EHS personnel to achieve project and production goals
Supports site reliability efforts by monitoring of key equipment performance variables and proactively identifies and addresses issues before they cause unplanned equipment downtime
Engage with both internal maintenance personnel and external vendors for issue resolution
Performs engineering tasks for the design, procurement, fabrication and/or commissioning phases associated with standard or custom build biotech systems
Independently leads 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)
Provides engineering support for the technology transfer of new products into existing manufacturing operations
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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North Carolina Biotechnology Center