Engineer III

CSL; Holly Springs (NC); On-site; USD 100,000 - 150,000; Full time

Job summary

CSL is seeking a Process Engineer III to provide engineering leadership for Drug Substance Manufacturing operations, including cell culture, purification, and process buffers. You will design, procure, install, and start-up equipment systems for an entire area and lead troubleshooting and CAPA programs.

The role requires onsite presence 5 days per week, with experience in regulated environments and a track record on complex projects and cross-functional teams.

Qualifications

• Bachelor’s degree in Engineering or related technical field with 7+ years of related industry experience, or Master’s degree with 4+ years 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.

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 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.

Skills

Leadership

Troubleshooting

Root cause analysis

Cross-functional teamwork

Continuous improvement

Education

Bachelor's degree in Engineering or related technical field

Master's degree in Engineering or related field

Job description

Purpose

The Process Engineer 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. Must be onsite 5 days per week

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 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.

Qualifications

• Bachelor's degree in Engineering or related technical field with 7+ years of related industry experience, or Master's degree with 4+ years 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.