Process Engineer I/II

Seqirus•Holly Springs, NC
•Onsite

About The Position

The Process Engineer I/II provides engineering support for Bulk Drug Substance Manufacturing operations. The role supports process equipment troubleshooting and assists with the design, procurement, installation, and start-up of process equipment systems. The position also performs engineering work across system design and commissioning, leads smaller engineering projects and change controls, and contributes to equipment performance, reliability, and continuous improvement.

Requirements

  • Bachelor’s degree in Engineering or a related technical field.
  • For Engineer I: bachelor’s degree and at least 1 year of related industry experience, or a master’s degree and at least 1 year of experience.
  • For Engineer II: bachelor’s degree and at least 3 years of related industry experience.

Nice To Haves

  • Experience in pharmaceutical or biotech 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 during the design, procurement, fabrication, and/or commissioning phases for 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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