Principal Engineer - SA-mRNA

Job Purpose:

Seqirus is seeking a lead process engineer who will provide technical/engineering support for site manufacturing operations with a focus on our mRNA program development. This will include technical oversight and leadership for the design, procurement, installation and start up of a clinical manufacturing facility.  Duties will also include equipment/process troubleshooting as well as ongoing performance analysis to improve overall equipment reliability.

• Subject Matter Expert (SME) in one or more of the following areas: drug substance and drug product manufacturing with a focus on cell culture and mRNA processes.
• Troubleshoots complex equipment related issues and develops sound engineering solutions to address identified problems for assigned systems
• Routinely interacts with internal manufacturing, QA, MS&T, validation, and EHS personnel to achieve project and production goals
• Engages with both internal maintenance personnel and external vendors for issue resolution
• Seeks out and implements performance and reliability improvements to positively impact production rates, efficiencies, and costs.
• Performs engineering tasks for the design, procurement, fabrication and/or commissioning phases associated with standard or custom build biotech systems
• Plans the execution of start-up and commissioning activities on assigned systems or areas.
• Supports the development and implementation of engineering standards and best practices.
• Independently leads small engineering projects
• Owns or supports change controls to complex engineering projects
• Leads cross functional teams to deliver on objectives
• Equipment lead for (DR) investigations to adequately identify root cause and implement appropriate corrective and preventative actions (CAPAs) to prevent reoccurrence.
• Participates in site audits by health authorities or other regulatory agencies (e.g. OSHA) for areas of expertise
• Provides engineering support for the technology transfer of new products into existing manufacturing operations

• BS Engineering or related field, graduate degree preferred.
• Minimum 5 years’ experience in process engineering in bio-manufacturing.  10+ years’ preferred.
• Direct experience with regulated environments (i.e. cGMP, OSHA, EPA) required
• Design experience or owners experience in process systems utilized in a biopharmaceutical or vaccine manufacturing process
• Established troubleshooting proficiency with complex, automated process systems
• Detailed knowledge of the process for vaccine manufacturing. Clean utilities, CIP, and formulation experience a plus as well as experience with automated PLC and DCS systems.
• Experience with mRNA vaccine manufacturing highly preferred.

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.