Commissioning & Qualification (C&Q) Engineer
vor 3 Wochen
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 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 Project/Qualification plans, protocols and reports on completed studiesSupport the creation of required master plans, standard operating procedures and work instructions ensuring these meet CSL global and site-specific procedures and regulatory requirementsWork along side validation contractors and project teams to achieve project deliverables
Your ExperienceEngineering degree (Pharmaceutical, Mechanical or Chemical) or equivalent in engineering, or related fieldExperience within a Commissioning and Qualification/Project function 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 tasksKnowledge 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. 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#J-18808-Ljbffr
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