Process Engineer II/III

CSL; Holly Springs (NC); On-site; USD 90,000 - 130,000; Full time

Job summary

CSL is seeking a Process Engineer II/III to provide engineering leadership for Drug Substance Manufacturing operations, including cell culture, purification, and preparation operations for process buffers and small equipment.

The role will lead design, procurement, installation, start-up, and commissioning of process equipment systems for an entire operational area, while driving continuous improvement and engineering standardization across teams.

Qualifications

• Bachelor’s degree in Engineering or related technical field.
• 3+ years (Engineer II) or 7+ years (Engineer III) of related industry experience, or Master’s degree with 1+ years (Engineer II) or 4+ years (Engineer III) of experience.
• Direct experience in pharmaceutical/biotech operations or other regulated environments (cGMP, OSHA, EPA).
• Design experience with pharmaceutical or biotech process or automation systems.
• Experience with medium or large projects to implement new or modified process equipment.
• Experience with cell culture/fermentation or protein purification processes is preferred.

Responsibilities

• Provides technical management and expertise for design, procurement, fabrication, and commissioning of custom equipment and automation of manufacturing systems.
• Leads cross-functional teams for technical continuous improvement projects.
• Plans execution of start-up and commissioning activities for assigned systems.
• Troubleshoots complex equipment- or automation-related issues and develops sound engineering solutions.
• Supports the development of engineering standards and best practices.
• Seeks out 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 deviation investigations related to process equipment to identify root cause and implement corrective and preventive actions (CAPAs).
• Trains other engineers and technical staff (Engineer III).

Skills

Process engineering

Troubleshooting

Project management

Cross-functional leadership

Root cause analysis

Education

Bachelor's degree in Engineering

Master's degree in Engineering

Job description

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

Responsibilities

• Provides technical management and expertise for the design, procurement, fabrication, and/or commissioning phases associated with custom equipment and/or automation of manufacturing systems.
• Leads cross-functional teams for technical continuous improvement projects.
• Plans the execution of start-up and commissioning activities for assigned systems for an operational area.
• Troubleshoots complex equipment- or automation-related issues and develops sound engineering solutions to address identified problems.
• Supports the development of engineering standards and best practices.
• Seeks out 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 deviation investigations related to process equipment to identify root cause and implement appropriate corrective and preventive actions (CAPAs) to prevent reoccurrence. Demonstrates mastery of root cause analysis methodologies.
• Trains other engineers and technical staff (Engineer III).

Qualifications

• Bachelor’s degree in Engineering or related technical field.
• Bachelor’s degree with 3+ years (Engineer II) or 7+ years (Engineer III) of related industry experience, or Master’s degree with 1+ years (Engineer II) or 4+ years (Engineer III) of experience.

• Direct experience in pharmaceutical/biotech operations or other regulated environments (e.g., cGMP, OSHA, EPA).
• Design experience with pharmaceutical or biotech process or automation systems.
• Experience with medium or large projects to implement new or modified process equipment.
• Experience with cell culture/fermentation 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