Process Engineer II/III
Compensation
EstimatedThe Role
Entity: CSL Seqirus
Job Category: Engineering
Job Family: Technical Services & Maintenance
Job Type: Full Time
Location:
HOLLY SPRINGS
, North Carolina, United States
Employer Reference: R-295606
Job Description
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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.
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.
Occupational Standards:
Bending/Reaching • For equipment operation or material movement tasks
Computer Use • May be for greater than 4 hours per day
Noise • Environment may exceed 80 decibels
Walking/Standing • Up to 8 hours throughout the workday
Lifting • Up to 40 lb
About CSL Seqirus
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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.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
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For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
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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.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
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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.
Benefits
Estimated- Competitive pay
- Health insurance
- Paid time off
- Growth opportunities
