Process Engineer II/III (Cell Culture / Vaccine Manufacturing)

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 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 Bulk operations.

• Subject Matter Expert (SME) for upstream or downstream process equipment
• 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 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 minor and major equipment upgrades
• Participate in site audits by health authorities or other regulatory agencies (e.g. OSHA)

• 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. 
• Experience with parenteral/aseptic processing preferred.
• Experience with the procurement, installation and validation of sterile single use systems.
• Vaccine bulk manufacturing experience.  Experience with bioreactors, ultra-filtration skids and chromatography purification technology.
• Key technical engineer part of the Material Response Team for the site.  Provides and leads engineering innovative solutions to ensure continuous manufacturing process and avoid product delays due to supply constraints.
• Strong communication skills with customers, design teams, contractors, and management.
• Action oriented skills; ability to learn on the fly.
• Good problem solving, technical learning, time management and prioritizing skills.
• Troubleshoots complex equipment related issues and develops sound engineering solutions to address identified problems for assigned systems.
• Routinely interact with manufacturing associates, maintenance staff, QA, 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 process equipment.
• Enable and support the Ethics & Compliance team at all levels within the organization, and proactively model ethical behaviours consistent with CSL Values: Patience Focus, Innovation, Integrity, Collaboration and Superior Performance.