Process Engineer (Bulk Drug Substance)

CSL Plasma•Holly Springs, NC

About The Position

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. Reporting to the Sr Manager you 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.

Requirements

Bachelor's degree Engineering or related technical field with 3+ years related industry experience, or Master's degree with 1+ years 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.