The Opportunity

The Process Engineering department at CSL Behring is recruiting for a Commissioning and Qualification (C&Q) Engineer to join our dynamic team at the Broadmeadows site. (This is a two year fixed term role when applicable)

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.

Your Responsibilities

Reporting to the Commissioning & Qualification (C&Q) Lead you will: 

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

Your Experience

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

To apply, submit your CV no later than Friday 17th January 2025.

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

About CSL Behring

CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

We want CSL to reflect the world around us

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

Do work that matters at CSL Behring!