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Senior Commissioning and Qualification
vor 4 Monaten
Your 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 guidelinesDevelop and evaluate systems (equipment, utilities, facilities, and processes) used to manufacture products in a Good Manufacturing Practice (GMP) environmentDevelop documentation for Qualification procedures and technical reportsSelect and manage validation contractors to achieve project deliverablesSupport preparation of proposals and bid packages to secure validation contractor servicesPrepare Project/Qualification plans, protocols and reports on completed studiesCreation of required master plans, standard operating procedures and work instructions ensuring these meet CSL global and site-specific procedures and regulatory requirementsAssist in budget preparation and forecasting for the scope of project and non-project activities. Ensure cost recovery is achieved where applicable
Your ExperienceEngineering degree (Pharmaceutical, Mechanical or Chemical) or equivalent in engineering, or related field5+ years experience within Commissioning and Qualification in pharmaceutical manufacturing or another regulated manufacturing industryFunctional 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 tasksExcellent 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 27th May 2024.
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 BehringVisit this company’s hub to learn about their values, culture, and latest jobs.Create a job alert and receive personalised job recommendations straight to your inbox.
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