CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients' needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas.

Description of the role

The Project Engineer will provide project and design support to the Project Manager or Senior Project Manager and the team to ensure that the specified project requirements are implemented to specification, time, quality and within budget to a successful handover to the end user. You will also support end-to-end delivery of Lifecycle Management (LCM) projects, ensuring regulatory, validation and operational readiness requirements are met.

Key Responsibilities:

• Support project activities as part of the team managed by Project Manager and/or Senior Project Manager.
• Works under limited supervision for routine situations
• Assist in the management of small to medium size projects (team typically less than 5 people; low to medium project complexity and technical complexity).
• Prepare and seek approval of Capital Expenditure Proposals, as instructed.
• Raise and administer purchase orders for supply of goods and services.
• Assist as directed in the preparation of key project management documents.
• Provide assistance as directed in maintaining the configuration management system during project activities.
• Plan and oversee execution of PPQ batches, stability studies, and cleaning validation activities, ensuring cross-functional alignment and timely issue resolution.
• Coordinate LCM changes within operating areas, planning work to minimise downtime and avoid impacts to routine manufacturing schedules.
• Prepare senior leadership updates on regulatory, validation and operational readiness status, including risk mitigation and contingency planning.
• Ensure that project tasks are managed in a way that creates a safe, healthy and secure workplace for the staff and contractors involved in implementing projects and for those using the facilities created or modified by these projects.
• Support lifecycle upgrades and process improvements that enhance product robustness, regulatory compliance, and operational efficiency, including coordinating validation strategy, PPQ readiness, and documentation updates

Qualifications and Experience required:

• Tertiary qualifications in engineering, or science.
• Strong understanding of GMP principles, qualification practices, validation lifecycle management and regulatory compliance requirements
• Proficiency in writing and executing qualification protocols (IQ/OQ/PQ), and supporting Process Performance Qualification (PPQ) activities
• Fundamental understanding of technical development concepts, tools and technologies as well as design techniques.
• Fundamental level of technical knowledge in one Engineering discipline and ability to solve problems in design, testing and deployment.
• Experience in troubleshooting, process engineering and ability to understand and implement client requirements. Experience
• An underlying Project Management experience.
• An underlying process and engineering systems/services experience gained in the GxP industry. Knowledge & Attributes
• An underlying knowledge of project management principles.
• Ability to manage multiple concurrent regulatory submission pathways and adjust project deliverables to meet varied global compliance requirement
• Strong stakeholder management skills, with proven ability to engage SMEs, global regulatory stakeholders and senior leadership
• Excellent communication skills (written and verbal).
• Intermediate skills in MS-Project, MS-Excel, MS-Word, MS-PowerPoint, MS-Visio and MS-Outlook.
• An underlying understanding and application of GxP principles.

• Support project activities as part of the team managed by Project Manager and/or Senior Project Manager.
• Works under limited supervision for routine situations
• Assist in the management of small to medium size projects (team typically less than 5 people; low to medium project complexity and technical complexity).
• Prepare and seek approval of Capital Expenditure Proposals, as instructed.
• Raise and administer purchase orders for supply of goods and services.
• Assist as directed in the preparation of key project management documents.
• Provide assistance as directed in maintaining the configuration management system during project activities.
• Plan and oversee execution of PPQ batches, stability studies, and cleaning validation activities, ensuring cross-functional alignment and timely issue resolution.
• Coordinate LCM changes within operating areas, planning work to minimise downtime and avoid impacts to routine manufacturing schedules.
• Prepare senior leadership updates on regulatory, validation and operational readiness status, including risk mitigation and contingency planning.
• Ensure that project tasks are managed in a way that creates a safe, healthy and secure workplace for the staff and contractors involved in implementing projects and for those using the facilities created or modified by these projects.
• Support lifecycle upgrades and process improvements that enhance product robustness, regulatory compliance, and operational efficiency, including coordinating validation strategy, PPQ readiness, and documentation updates

• Proficiency in writing and executing qualification protocols (IQ/OQ/PQ), and supporting Process Performance Qualification (PPQ) activities
• Fundamental understanding of technical development concepts, tools and technologies as well as design techniques.
• Fundamental level of technical knowledge in one Engineering discipline and ability to solve problems in design, testing and deployment.
• Experience in troubleshooting, process engineering and ability to understand and implement client requirements.
• An underlying knowledge of project management principles.
• Ability to manage multiple concurrent regulatory submission pathways and adjust project deliverables to meet varied global compliance requirement
• Strong stakeholder management skills, with proven ability to engage SMEs, global regulatory stakeholders and senior leadership
• Excellent communication skills (written and verbal).
• Intermediate skills in MS-Project, MS-Excel, MS-Word, MS-PowerPoint, MS-Visio and MS-Outlook.
• An underlying understanding and application of GxP principles.

• Tertiary qualifications in engineering, or science.
• Strong understanding of GMP principles, qualification practices, validation lifecycle management and regulatory compliance requirements
• An underlying Project Management experience.
• An underlying process and engineering systems/services experience gained in the GxP industry.