Process Engineer I/II

CSL; Holly Springs (AL); Presencial; USD 65.000 - 90.000; Jornada completa

Descripción de la vacante

CSL Seqirus in Holly Springs, NC, is seeking a Process Engineer I/II to provide engineering support for Bulk Drug Substance manufacturing. You will troubleshoot process equipment, participate in design, procurement, installation, and start-up of systems, and drive continuous improvement.

The role requires a engineering degree and relevant experience in regulated environments; experience with cell culture/fermentation or protein purification is preferred.

Formación

• Bachelor’s degree in Engineering or related technical field.
• 1+ years Eng I or 3+ years Eng II experience, or Master’s degree with 1+ year's experience.
• Experience in pharmaceutical/biotech operations or other regulated environments (e.g., cGMP, OSHA, EPA) is preferred.
• Experience with cell culture/fermentation and/or protein purification processes is preferred.

Responsabilidades

• Provides technical review of design documents for assigned systems.
• Performs engineering tasks for the design, procurement, fabrication, and/or commissioning phases associated with standard or custom systems.
• Independently leads small engineering projects and change controls including concept, funding requests, and approvals.
• Independently performs start-up and commissioning activities on assigned systems.
• Troubleshoots complex equipment and/or automation related issues and develops sound engineering solutions to address identified problems for assigned systems.
• Recommends and implements performance and reliability improvements for assigned systems.
• Leads complex deviation (DR) investigations to adequately identify root cause and implement appropriate corrective and preventive actions (CAPAs).
• Collaborates within the Process Engineering team as well as with other functions to accomplish continuous improvement projects and initiatives.

Educación

Bachelor’s degree in Engineering or related field

Descripción del empleo

Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges? Seqirus has an exciting opportunity to join our expanding team in Holly Springs, NC. With the state-of-the-art manufacturing facility and an expertise in influenza science we are one of the world leaders in the production of the influenza vaccine. We operate as one integrated global company, drawing together expert staff from different countries to collaborate. Together, we're working to protect communities from seasonal influenza and global pandemic threats. When you join Seqirus, you join a team dedicated to making a difference in people's lives. It's a feeling of possibility, creativity, and purpose that inspires us every day.

Job Purpose

The Process Engineer I / II will provide engineering support for Bulk Drug Substance Manufacturing operations. This includes process equipment troubleshooting as well as assisting in the design, procurement, installation, and start-up of process equipment systems.

Major Responsibilities

• Provides technical review of design documents for assigned systems
• Performs engineering tasks for the design, procurement, fabrication, and/or commissioning phases associated with standard or custom systems
• Independently leads small engineering projects and change controls including concept, funding requests, and approvals
• Independently performs start-up and commissioning activities on assigned systems
• Troubleshoots complex equipment and/or automation related issues and develops sound engineering solutions to address identified problems for assigned systems
• Recommends and implements performance and reliability improvements for assigned systems
• Leads complex deviation (DR) investigations to adequately identify root cause and implement appropriate corrective and preventive actions (CAPAs).
• Collaborates within the Process Engineering team as well as with other functions to accomplish continuous improvement projects and initiatives.

Qualifications

• Education: Bachelor’s degree in Engineering or related technical field.
• Experience: Bachelor’s degree with 1+ years (Eng I) or 3+ years (Eng II) related industry experience, or Master’s degree with 1+ year's experience.
• Experience: Experience in pharmaceutical/biotech operations or other regulated environments (e.g., cGMP, OSHA, EPA) is preferred.
• Experience: Experience with cell culture/fermentation and/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

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

For more information on CSL benefits visit https://www.csl.com/ and https://www.cslplasma.com/.

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.

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

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.

Watch our ‘On the Front Line’ video to learn more about CSL Seqirus