Senior Operational Services Associate –Change Projects

Csl Behring; City of Melbourne; On-site; AUD 90,000 - 110,000; Full time

Job summary

CSL Behring Broadmeadows, VIC, AU seeks a Senior Operational Services Associate – Change Projects to lead complex compliance activities within the Operational Services team across Fractionation, Bulk, Filling and Visual Inspection and Packing Value Streams.

The role focuses on managing deviations, CAPAs, audits and change management in a regulated manufacturing environment, with a strong emphasis on continuous improvement and stakeholder collaboration.

Qualifications

• Experience in deviations, CAPAs, audits, inspections and change management in GMP environments.
• Strong understanding of GMP and continuous improvement in live production.
• Ability to facilitate cross-functional teams and influence stakeholders to drive investigations or changes to completion.

Responsibilities

• Execute and coordinate changes through the Change Management System per priorities and timelines.
• Lead deviation investigations and support CAPA development.
• Ensure compliant documentation and evidence management practices.
• Facilitate cross-functional teams to complete investigations, changes, and improvement initiatives.
• Build partnerships with Manufacturing, Quality, Engineering and Safety stakeholders.
• Analyse trends to identify opportunities for process improvement and simplification.
• Coach and share knowledge to support capability development.

Skills

Change management

CAPA investigations

GMP compliance

Veeva/TrackWise

Cross-functional collaboration

Regulated manufacturing

Education

Bachelor's degree in Science/Engineering or related discipline

Tools

Veeva

TrackWise

Job description

Senior Operational Services Associate –Change Projects CSL Behring Broadmeadows, VIC, AU

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.

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.