Process Engineer II/III/Principle (Utilities)

Job Purpose:

Provides technical expertise for site utility equipment and systems. The Process Engineer II/III/Principle 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.
 

• 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)

B.S. degree in an Engineering discipline is required.

Minimum of 5 years of relevant experience with HVAC and Utilities required.

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.

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

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.

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.

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