Process Engineer III (Pharmaceutical/Biotechnology)

CSL; Holly Springs (NC); On-site; USD 120,000 - 150,000; Full time

Job summary

CSL Seqirus is seeking an engineering leader to provide technical management for Drug Substance Manufacturing operations, including cell culture, purification, and preparation of process buffers and small equipment.

You will lead design, procurement, installation, and start-up of process equipment systems for an entire operational area, and onsite execution five days a week, with responsibility for debugging, CAPAs, and continuous improvement.

Qualifications

• Bachelor’s degree in Engineering or related field with 7+ years of experience (or Master’s with 4+ years).
• Experience in pharmaceutical/biotech operations or other regulated environments (cGMP, OSHA, EPA).
• Design experience with pharma/biotech process or automation systems.
• Experience with medium/large projects to implement new or modified process equipment.
• Experience with cell culture/fermentation or protein purification preferred.

Responsibilities

• Provides technical management and expertise for design, procurement, fabrication, and commissioning phases for custom equipment or automation of manufacturing systems.
• Leads cross-functional teams for technical continuous improvement projects.
• Plans start-up and commissioning activities for assigned systems.
• Troubleshoots complex equipment- or automation-related issues and develops engineering solutions.
• Supports development of engineering standards and best practices.
• Seeks performance and reliability improvements for assigned systems.
• Owns or supports complex small projects and/or capital projects, including change management strategies.
• Leads deviation investigations to identify root cause and implement CAPAs to prevent recurrence.
• Trains other engineers and technical staff.

Skills

Technical leadership

Troubleshooting

CAPA/root cause analysis

Cross-functional leadership

Equipment design

Project management

Training others

Education

Bachelor’s degree in Engineering or related field

Master’s degree in Engineering or related field

Tools

Pharma/biotech process design tools

Automation systems design

Job description

You 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.

About CSL Seqirus

CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.