Senior Operational Services Associate – Change Projects

CSL Limited; City of Melbourne; On-site; AUD 100,000 - 140,000; Full time

Job summary

CSL Behring in Melbourne seeks a Senior Operational Services Associate - Change Projects to lead complex compliance activities within our Operational Services team across Fractionation, Bulk, Filling, Visual Inspection and Packing value streams at Broadmeadows.

You will drive change through the Change Management System, lead deviation investigations, support CAPA development, ensure robust documentation and evidence management, and coach cross-functional teams to deliver improvements in a live

Qualifications

• Demonstrated experience in regulated manufacturing environments.
• Experience managing deviations, CAPAs, audits, inspections and change management with a compliance focus.
• Strong understanding of GMP requirements and continuous improvement in live production.

Responsibilities

• Execute and coordinate changes through the Change Management System according to priorities and timelines.
• Lead deviation investigations and support CAPA development.
• Ensure strong compliance, 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.
• Support capability development through coaching and knowledge sharing.

Skills

GMP knowledge

Cross-functional collaboration

CAPA investigations

Veeva/TrackWise experience

Education

Science/Engineering degree or equivalent

Tools

Veeva

TrackWise

Job description

Senior Operational Services Associate – Change Projects

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.

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.