Process Engineer II/III

CSL • Holly Springs, NC

23h

About The Position

The Process Engineer II / III provides engineering support and leadership for Drug Substance Manufacturing operations, including cell culture, purification, and/or preparation operations for process buffers and small equipment. The role serves as a technical leader responsible for troubleshooting process equipment and for the design, procurement, installation, and start-up of process equipment systems across an operational area.

The engineer provides technical management for custom equipment and manufacturing-system automation, leads cross-functional continuous-improvement work, and plans start-up and commissioning activities. The role also addresses complex equipment- and automation-related issues, improves system performance and reliability, supports engineering standards and best practices, and owns or supports small and capital projects. The Engineer III additionally trains other engineers and technical staff.

Requirements

• Bachelor’s degree in Engineering or a related technical field.
• For Engineer II: 3+ years of related industry experience with a bachelor’s degree, or 1+ years with a master’s degree.
• For Engineer III: 7+ years of related industry experience with a bachelor’s degree, or 4+ years with a master’s degree.
• Direct experience in pharmaceutical/biotech operations or other regulated environments, such as cGMP, OSHA, or EPA.
• Design experience with pharmaceutical or biotech process or automation systems.
• Experience with medium or large projects implementing new or modified process equipment.
• Mastery of root-cause analysis methodologies for complex equipment-related deviation investigations.

Nice To Haves

• Experience with cell culture/fermentation or protein purification processes.

Responsibilities

• Provides technical management and expertise for the design, procurement, fabrication, and/or commissioning of custom equipment and manufacturing-system automation.
• Leads cross-functional teams for technical continuous-improvement projects.
• Plans start-up and commissioning activities for assigned systems within an operational area.
• Troubleshoots complex equipment- or automation-related issues and develops engineering solutions.
• Supports development of engineering standards and best practices.
• Identifies and implements performance and reliability improvements for assigned systems.
• Owns or supports complex small projects and/or capital projects, including change-management strategies.
• Leads complex process-equipment deviation investigations, identifies root causes, and implements corrective and preventive actions (CAPAs) to prevent recurrence.
• Trains other engineers and technical staff (Engineer III).

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level