Process Engineer II/III
CSL
Summary
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.
Job description
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.
Requirements
- 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
Company overview
CSL Limited is an Australian multinational specialty biotechnology company that researches, develops, manufactures, and markets products to treat and prevent serious human medical conditions. Founded in 1916 as Commonwealth Serum Laboratories, CSL has grown to become the world's fifth largest biotechnology company with operations in over 35 countries. The company specializes in blood plasma derivatives, vaccines, antivenoms, and cell culture reagents used in medical and genetic research applications. CSL operates through several key divisions including CSL Behring (focusing on rare and serious diseases), CSL Seqirus (one of the world's largest influenza vaccine providers), CSL Plasma, and CSL Vifor. With over 32,000 employees globally, CSL maintains a strong R&D pipeline and has invested over US$3.3 billion in research and development over the past five years. The company is publicly traded on the Australian Securities Exchange and has its global headquarters in Parkville, Melbourne, Australia.