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Senior Operational Services Associate –Change Projects

CSL
Broadmeadows, AUS
Full-time
Mid-Senior
Onsite
Discovered 1 weeks ago
Change managementDeviation investigationsCAPA developmentGMP-regulated manufacturingCompliance documentation and evidence managementCross-functional facilitation
Free

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Key skills for this role

Change managementDeviation investigationsCAPA development
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Role Overview

CSL Behring is seeking Senior Operational Services Associate - Change professionals for its Operational Services team at Broadmeadows.

The roles support the Fractionation, Bulk, Filling, and Visual Inspection and Packing value streams.

The work focuses on complex compliance activities in regulated manufacturing operations.

Employment Duration

  • Multiple fixed-term positions are available for 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 completing investigations, changes and improvement initiatives.
  • Partner with Manufacturing, Quality, Engineering and Safety stakeholders.
  • Analyse trends to identify process improvement and simplification opportunities.
  • Support capability development through coaching, knowledge sharing and practical guidance.

Preferred Skills and Experience

  • Tertiary qualification in Science, Engineering or a related discipline, or equivalent regulated manufacturing experience.
  • Experience in pharmaceutical, biotechnology, biologics or other GMP-regulated manufacturing environments.
  • Experience managing deviations, CAPAs, audits, inspections or change management activities.
  • Strong understanding of manufacturing operations, GMP requirements and continuous improvement in live production.
  • Ability to facilitate cross-functional teams, influence stakeholders and complete investigations or change initiatives.
  • Strong analytical, root cause investigation, organisational and technical writing skills.
  • Experience with Veeva and/or TrackWise is highly regarded.

Application

  • Applicants should provide a CV and cover letter.

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