Engineer III
CSL · Holly Springs, NC · 1 mo ago
EngineeringFull-time
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.
- Led 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.
- Sets out and implements performance and reliability improvements for assigned systems.
- Owes 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).
- 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.