Process Engineer I/II

CSL; Holly Springs (NC); On-site; USD 70,000 - 110,000; Full time

Job summary

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

The role involves technical reviews, startup activities, and leading small projects within a regulated environment to drive continuous improvement and CAPA implementations.

Qualifications

• Bachelor’s degree with 1+ years (Eng I) or 3+ years (Eng II) related industry 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 technical field

Job description

Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges? Seqirus has an exciting opportunity to join our expanding team in Holly Springs, NC. With the state‑of-the-art manufacturing facility and an expertise in influenza science we are one of the world leaders in the production of the influenza vaccine. We operate as one integrated global company, drawing together expert staff from different countries to collaborate. Together, we're working to protect communities from seasonal influenza and global pandemic threats. When you join Seqirus, you join a team dedicated to making a difference in people's lives. It's a feeling of possibility, creativity, and purpose that inspires us every day.

Job Purpose

The Process Engineer I / II will provide engineering support for Bulk Drug Substance Manufacturing operations. This includes process equipment troubleshooting as well as assisting in the design, procurement, installation, and start-up of process equipment systems.

Major 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.

Qualifications

Education Bachelor’s degree in Engineering or related technical field.

• Experience Bachelor’s degree with 1+ years (Eng I) or 3+ years (Eng II) related industry 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.

Occupational Standards

• Bending/Reaching For equipment operation or material movement tasks
• Computer Use May be for greater than 4 hours per day
• Noise Environment may exceed 80 decibels
• Walking/Standing Up to 8 hours throughout the workday
• Lifting Up to 40 lb.