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.
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.
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To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
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