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Commissioning & Qualification (C&Q) Engineer

4 months ago

Broadmeadows, Australia CSL Full time

Your Role

The Process Engineering function at CSL Behring is recruiting multiple roles within our Commissioning & Qualification (C&Q) team, these are permanent positions at our Broadmeadows site.

You will apply fundamental engineering knowledge for the design and implementation of new process technology 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, Quality, and Regulatory Affairs alongside and as a pivotal representative of the Process Engineering (PE) organisation

Your Responsibilities

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

Execute risk based qualification 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 Project/Qualification plans, protocols and reports on completed studies 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 along side validation contractors and project teams to achieve project deliverables

Your Experience

Engineering degree (Pharmaceutical, Mechanical or Chemical) or equivalent in engineering, or related field Experience within a Commissioning and Qualification/Project function in pharmaceutical manufacturing or another regulated manufacturing industry 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

To apply, submit your CV no later than Monday 24th June 2024.

Our Benefits

We encourage you to make your well-being a priority. It’s important and so are you.