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Principal Engineer (Utilities) at CSL Plasma

Principal Engineer (Utilities)

CSL Plasma Holly Springs, NC Full-Time
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About CSL

With operations in 35+ nations and ~27,000 employees worldwide, CSL is driven to develop and deliver a broad range of lifesaving therapies to treat disorders such as hemophilia and primary immune deficiencies, and vaccines to prevent influenza. Our therapies are also used in cardiac surgery, organ transplantation and burn treatment.

CSL is the parent company of CSL Behring and Seqirus. CSL Behring is a global leader in the protein biotherapeutics industry, focused on bringing to market biotherapies used to treat serious and often rare conditions. CSL Behring operates CSL Plasma, one of the world's largest collectors of human plasma, which is used to create CSL’s therapies. Seqirus is one of the largest influenza vaccine companies in the world and is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally.

We invite you to take a look at the many career possibilities available around the globe and consider building your promising future at CSL by becoming a member of our team!


Job Description



Job Purpose:


Provides technical expertise for site utility equipment and systems. The Principal Engineer will work closely with internal customers to provide and/or facilitate engineering for plant-wide utility operations. Responsibilities will include:  design, procurement, installation, start-up, commissioning and ongoing operations of GMP and non-GMP utilities.



Major Accountabilities:

  • Subject Matter Expert (SME) for GMP utilities such as clean steam, clean compressed air, water for injection (WFI), USP water and HVAC systems aligned with the manufacturing process of pharmaceutical drug substance and sterile drug product.

  • Troubleshoots equipment related issues and develops sound engineering solutions to address identified problems for assigned systems.

  • Routinely interact with utility operators and maintenance staff, QA, MS&T, Validation, and EHS personnel to achieve project and production goals.

  • Involved with 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 utility systems.

  • Applies knowledge of engineering principles and best practices.

  • Independently leads engineering projects.

  • Initiate and own change controls for equipment modifications.

  • Works within SAP to generate work orders and enter Spare Parts/PMs for utility systems and equipment.

  • Responsible for investigations to adequately identify root cause and implement appropriate corrective and preventative actions (CAPAs) to prevent reoccurrence.

  • Responsible for the execution of planned shutdowns, start-up and commissioning activities for minor and major equipment upgrades.

  • Participates in site audits by health authorities or other regulatory agencies (e.g. OSHA).



Minimum Requirements:

  • B.S. degree in an Engineering discipline is required, Masters degree preferred.

  • Minimum of 5 years of relevant experience with HVAC and Utilities required. 8+ years preferred.

  • Previous experience in pharmaceutical or manufacturing environment.

  • Strong understanding of cGMP / Engineering within an FDA regulated operation.

  • Strong experience with Change Controls, Root Cause Analysis, Deviations and CAPA investigations.

 

Recommended skills

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Job ID: R-124074

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