AddressYour Role
The Process Engineering function at CSL Behring is recruiting for multiple Senior Commissioning and Qualification (C&Q) Engineers to join our team at the Broadmeadows site.
This is a two year fixed term role where 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:
- Plan and execute risk based qualification in compliance with company standards and regulatory guidelines
- Develop and evaluate systems (equipment, utilities, facilities, and processes) used to manufacture products in a Good Manufacturing Practice (GMP) environment
- Develop documentation for Qualification procedures and technical reports
- Select and manage validation contractors to achieve project deliverables
- Support preparation of proposals and bid packages to secure validation contractor services
- Prepare Project/Qualification plans, protocols and reports on completed studies
- Creation of required master plans, standard operating procedures and work instructions ensuring these meet CSL global and site-specific procedures and regulatory requirements
- Assist in budget preparation and forecasting for the scope of project and non-project activities. Ensure cost recovery is achieved where applicable
- Engineering degree (Pharmaceutical, Mechanical or Chemical) or equivalent in engineering, or related field
- 5+ years experience within Commissioning and Qualification 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
- Excellent knowledge of industry guidance documents and standards, with a good understanding of validation and Qualification principles
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.
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