Process Engineer I/II

CSL•Holly Springs, NC
•Onsite

About The Position

The Process Engineer I/II provides engineering support for Bulk Drug Substance Manufacturing operations. This includes troubleshooting process equipment and assisting with the design, procurement, installation, and start-up of process equipment systems. The position is based at Seqirus’s manufacturing facility in Holly Springs, North Carolina.

Requirements

  • Bachelor’s degree in Engineering or a related technical field, with at least 1 year of related industry experience for Engineer I or 3 years for Engineer II; alternatively, a Master’s degree with at least 1 year of experience.
  • Ability to perform the engineering responsibilities described for the role.

Nice To Haves

  • Experience in pharmaceutical or biotechnology operations, or other regulated environments such as cGMP, OSHA, or EPA.
  • Experience with cell culture/fermentation and/or protein purification processes.

Responsibilities

  • Provide technical review of design documents for assigned systems.
  • Perform engineering tasks for the design, procurement, fabrication, and/or commissioning of standard or custom systems.
  • Independently lead small engineering projects and change controls, including concept development, funding requests, and approvals.
  • Independently perform start-up and commissioning activities on assigned systems.
  • Troubleshoot complex equipment and automation-related issues and develop engineering solutions for assigned systems.
  • Recommend and implement performance and reliability improvements for assigned systems.
  • Lead complex deviation investigations to identify root causes and implement appropriate corrective and preventive actions (CAPAs).
  • Collaborate with the Process Engineering team and other functions on continuous improvement projects and initiatives.
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