Facility Operations Manager

3 weeks ago

Parkville, Victoria, Australia CSL Full time

The Opportunity

CSL is a leading global biotechnology company with a dynamic portfolio of life-saving medicines, including those that treat haemophilia and immune deficiencies, as well as vaccines to prevent influenza.

We are currently recruiting for a Facility Operations Manager to join our Building Operations & Services team at our Melbourne office.

Reporting to the Associate Director, Building Operations & Services, you will be responsible for implementing the CPA and CPS support strategy for the CSL Melbourne facility. You will provide real-time troubleshooting for manufacturing scale processes to effectively support facilities, systems, and infrastructure on the CSL Melbourne site relating to CPS and CPA facility support services.

This role will require you to provide strategic definition, management, and direction for assigned resources to effectively support the maintenance of facilities, systems, and infrastructure on the CSL Melbourne site relating to GxP facility and lab services.

The Role

  • Manage Facility Support Services team for CSL Melbourne, including full-time staff, contingent labor, and contractors.
  • Manage Facility Support Services activities within the CPA Wash, CPA Solution Preparation, and CPS areas.
  • Provide operational and technical support assistance during peak processing loads.
  • Provide technical support and troubleshooting for manufacturing processes – including solution preparation and support services (e.g., washing, autoclaving).
  • Act as an SME on service agreements for servicing CSL Melbourne Wash, Solution Preparation, and equipment by third-party/external vendors and ensure contract provisions adhered to by all parties.
  • Provide operational and technical support within the CPA and CPS for Apprentice.IO – including generation of new batch records, augmentation of records, completion, and review once batches complete.
  • Ensure staff maintain OGTR, GSP, DAWR, and safety standards when working in these areas.
  • Identify, implement, and monitor initiatives that maintain and/or improve solution preparation processes.
  • Review, update, and implement core CPA and CPS support procedures and training requirements to ensure compliance and data integrity.
  • Manage change controls and deviation investigations related to operations within the CPA Solution Preparation facility and CPS support functions to ensure timely completion of corrective and preventive actions.
  • Collaborate in facility GMP and technical audits and assist in the resolution of internal and external audit findings.

Your Skills and Experience

  • Postgraduate degree (Bachelor of Science or equivalent degree) and/or experience in a relevant discipline.
  • 6+ years in manufacturing operations.
  • Demonstrated knowledge of GLP, GMP, and ICH guidelines.
  • Excellent knowledge of change control and deviation management, including being skilled in technical writing.
  • Management experience in service provider, contract, reports on KPIs, and budget.
  • Demonstrated ability to provide staff oversight and conduct workflow planning.
  • Knowledge and skills in ERP systems such as SAP, including understanding of inventory management principles.
  • Experience in implementation of 6 sigma/5S principles is highly desirable.
  • Operational management experience and knowledge of validation (autoclave and washing machine) is highly desirable.
  • Excellent communication and analytical skills.
  • High level of attention to detail and well-developed problem-solving abilities.

How to Apply

Please submit your application including your CV and cover letter.

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