The Opportunity

The Process Engineering department at CSL Behring is recruiting multiple Commissioning and Qualification (C&Q) Engineers to join our dynamic team at the Broadmeadows site.

As a C&Q Engineer, you will apply fundamental engineering knowledge for the design and implementation of new process technology, including highly automated processing equipment, facilities, utilities and processes, as part of our high priority expansion projects.

You will work with a broad range of local and global counterparts and functions as diverse as Manufacturing, Project Delivery (PD) incl. Project Management Operations, Quality, and Regulatory Affairs alongside and as a pivotal representative of the Process Engineering (PE) organisation. You will also closely work and partner with the rest of the PE organisation, including Process Technology (PT), Manufacturing Science and Technology (MS&T), Execution Systems, Validation and Stability.

• Execute risk-based qualification activities in compliance with company standards and regulatory guidelines
• Commissioning and qualify systems (equipment, utilities, facilities, and processes) used to manufacture products in a Good Manufacturing Practice (GMP) environment
• Develop documentation for qualification/verification procedures and technical reports
• Prepare qualification plans, protocols and reports on completed studies, to support engineering projects and critical operations requests
• Support the creation of required master plans, standard operating procedures and work instructions ensuring these meet CSL global and site-specific procedures and regulatory requirements
• Work alongside engineering contractors and project teams to achieve project deliverables and to support critical operations requests

• Engineering degree (Pharmaceutical, Mechanical or Chemical) or equivalent / related field
• Experience within a Commissioning and Qualification function in pharmaceutical manufacturing or another regulated manufacturing industry
• Experience in project, production or process engineering within pharmaceutical manufacturing or another regulated manufacturing industry would be ideal
• Functional knowledge of cGMPs and manufacturing operations in FDA regulated facility would be an advantage
• Experience using strong verbal and written communication skills to present to a range of audiences at all levels within an organisation
• Excellent time management skills, with the flexibility to manage changing priorities and multiple tasks
• Knowledge of industry guidance documents and standards, with a good understanding of validation and qualification principles