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Engineer II / III

CSL Behring
Holly Springs, North Carolina
Start date
Sep 26, 2023

Job Details

Job Description

Job Summary:

Act as Process Engineer in carrying out assigned process-related improvement projects in compliance with safety and regulatory requirements during all phases of assigned projects. The role will support the design, procurement, installation of GMP process equipment supporting vaccine manufacturing operations. In addition, the engineer will work closely with internal customers to provide and/or facilitate engineering support for Formulation and Filling operations.

Major Accountabilities:

  • Subject Matter Expert (SME) for Formulation/Filling process equipment, including isolator technology.  Equipment include: formulation vessels, microfluidizer, syringe filling machine, e-Beam sterilizer and isolators.
  • Troubleshoots complex equipment related issues and develops sound engineering solutions to address identified problems for assigned systems
  • Routinely interact with internal manufacturing, QA, MS&T, validation, and EHS personnel to achieve project and production goals
  • Supports site reliability efforts by monitoring of key equipment performance variables and proactively identifies and addresses issues before they cause unplanned equipment downtime
  • Engage with both internal maintenance personnel and external vendors for issue resolution
  • Performs engineering tasks for the design, procurement, fabrication and/or commissioning phases associated with standard or custom build biotech systems
  • Independently leads small to medium engineering projects.
  • Initiate and own change controls for equipment modifications
  • Equipment lead for (DR) investigations to adequately identify root cause and implement appropriate corrective and preventative actions (CAPAs) to prevent reoccurrence.
  • Lead for the execution of start-up and commissioning activities for equipment upgrades
  • Participate in site audits by health authorities or other regulatory agencies (e.g. OSHA)

Minimum Qualifications:

  • Bachelor’s degree in Chemical Engineering, Mechanical Engineering or equivalent preferred with at least 3-5+ years of experience in cGMPs and manufacturing operations in an FDA regulated facility. 
  • Process Engineering experience with parenteral/aseptic processing is a most.
  • Experience with the procurement, installation and validation of sterile single use systems.
  • Strong communication skills with customers, design teams, contractors, and management.
  • Good problem solving, technical learning, time management and prioritizing skills.
  • Troubleshooting experience with complex equipment related issues developing sound engineering solutions.
  • Enable and support the Ethics & Compliance team at all levels within the organization, and proactively model ethical behaviors consistent with CSL Values: Patience Focus, Innovation, Integrity, Collaboration and Superior Performance.

About Us

Our Benefits

Seqirus is committed to attracting and retaining world-class employees who are valued for their contributions to achieving business objectives. Learn more about some of the benefits you can participate in when you join Seqirus.

About Seqirus

Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world, Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about Seqirus.

We want Seqirus to reflect the world around us

As a global organisation with employees in 35+ countries, CSL embraces diversity, equity and inclusion. Learn more about Diversity, Equity & Inclusion at Seqirus.

Do work that matters at Seqirus!


As the third largest global biotechnology company with employees in more than 35 countries, CSL Behring is focused on serving patients with serious and rare diseases, including coagulation disorders, primary immune deficiencies, hereditary angioedema, respiratory disease and neurological disorders. We collaborate with patient and biomedical communities to improve access to therapies, advance scientific knowledge and support future medical research. 

CSL Behring's dynamic environment fosters innovation and attracts the best and brightest who share a commitment to helping save lives. People here are free to live their Promising FUTURES where they can fulfill their individual career aspirations and realize their potential. 

CSL Behring is committed to diversity and inclusion, both of which underpin our Values of patient focus, innovation, collaboration, integrity and superior performance. We believe that by harnessing and honoring the unique capabilities, experiences and perspectives of our people, we are better able to serve our patients.

CSL Behring operates one of the world's largest plasma collection networks, CSL Plasma. The parent company, CSL Limited, headquartered in Melbourne, Australia, employs more than 27,000 people, and provides its life-saving medicines in more than 70 countries. 
For more information visit Help us deliver on our promise to save lives and protect the health of people around the world. Promising FUTURES start at CSL Behring!

Stock Symbol: CSL

Stock Exchange: Australian Securities Exchange

Company info
1020 First Avenue
King of Prussia
United States

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