Process Engineer I/II – Biopharma Manufacturing & Startup

CSL; Holly Springs (AL); On-site; USD 65,000 - 90,000; Full time

Job summary

CSL Seqirus in Holly Springs, NC, is seeking a Process Engineer I/II to provide engineering support for Bulk Drug Substance manufacturing. You will troubleshoot process equipment, participate in design, procurement, installation, and start-up of systems, and drive continuous improvement.

The role requires a engineering degree and relevant experience in regulated environments; experience with cell culture/fermentation or protein purification is preferred.

Qualifications

• Bachelor’s degree in Engineering or related technical field.
• 1+ years Eng I or 3+ years Eng II experience, or Master’s degree with 1+ year's experience.
• Experience in pharmaceutical/biotech operations or other regulated environments (e.g., cGMP, OSHA, EPA) is preferred.
• Experience with cell culture/fermentation and/or protein purification processes is preferred.

Responsibilities

• Provides technical review of design documents for assigned systems.
• Performs engineering tasks for the design, procurement, fabrication, and/or commissioning phases associated with standard or custom systems.
• Independently leads small engineering projects and change controls including concept, funding requests, and approvals.
• Independently performs start-up and commissioning activities on assigned systems.
• Troubleshoots complex equipment and/or automation related issues and develops sound engineering solutions to address identified problems for assigned systems.
• Recommends and implements performance and reliability improvements for assigned systems.
• Leads complex deviation (DR) investigations to adequately identify root cause and implement appropriate corrective and preventive actions (CAPAs).
• Collaborates within the Process Engineering team as well as with other functions to accomplish continuous improvement projects and initiatives.

Education

Bachelor’s degree in Engineering or related field

Job description

CSL Seqirus in Holly Springs, NC, is seeking a Process Engineer I/II to provide engineering support for Bulk Drug Substance manufacturing. You will troubleshoot process equipment, participate in design, procurement, installation, and start-up of systems, and drive continuous improvement.

The role requires a engineering degree and relevant experience in regulated environments; experience with cell culture/fermentation or protein purification is preferred.