Senior Operational Services Associate –Change Projects

CSL Behring · Broadmeadows VIC 3047 · Full time
Posted 7d ago

Senior Operational Services Associate –Change Projects

KEY POINTS WE FOUND
  • Lead complex compliance activities within Operational Services team.
  • Execute and coordinate changes through the Change Management System.
  • Facilitate cross-functional teams to complete investigations and improvement initiatives.

Join CSL Behring and play a critical role in supporting safe, reliable, and compliant manufacturing operations that help deliver life-saving therapies to patients around the world.

We are seeking Senior Operational Services Associate-Change (Multiple positions) to lead complex compliance activities within our Operational Services team supporting the Fractionation, Bulk, Filling and Visual Inspection and Packing Value Streams at Broadmeadows. This role is ideal for an experienced professional with a strong background in regulated manufacturing environments who thrives on problem solving, stakeholder collaboration, and continuous improvement.

We are hiring for multiple fixed term positions (12 or 24 Months).

Key Responsibilities

  • Execute and coordinate changes through the Change Management System according to agreed priorities and timelines.

  • Lead deviation investigations and support robust CAPA development.

  • Ensure strong compliance, documentation, and evidence management practices.

  • Facilitate cross-functional teams to complete investigations, changes, and improvement initiatives.

  • Build strong partnerships with Manufacturing, Quality, Engineering, and Safety stakeholders.

  • Analyse trends to identify opportunities for process improvement and simplification.

  • Support capability development through coaching, knowledge sharing, and practical guidance.

Preferred Skills & Experience

  • A tertiary qualification in Science, Engineering or a related discipline, or equivalent experience within a regulated manufacturing environment. 

  • Experience in pharmaceutical, biotechnology, biologics or other GMP-regulated manufacturing environments.

  • Demonstrated experience managing deviations, CAPAs, audits, inspections and/or change management activities, with a strong focus on compliance outcomes. 

  • Strong understanding of manufacturing operations, GMP requirements and continuous improvement within a live production environment.

  • Proven ability to facilitate cross-functional teams, influence stakeholders and drive investigations or change initiatives to successful completion.

  • Excellent analytical, root cause investigation, organisational and technical writing skills. Experience with Veeva and/or TrackWise is highly regarded.

How to Apply

Apply now to step into a varied and impactful role within an organisation undergoing significant investment and transformation.
Please include your CV and Cover Letter with your application.

We are committed to attracting talented individuals from diverse backgrounds. If you are interested in this opportunity and can demonstrate many, but not all, of the capabilities required, we encourage you to apply.

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Skills

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Analytical skillsCapa developmentChange managementContinuous improvementCross-functional team facilitationDeviation investigationGmp regulationsProblem solvingProcess improvementRoot cause analysisStakeholder collaborationTechnical writingTrackwiseVeeva

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