Lead Process Engineer, Biotech Manufacturing & Automation

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

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.