QC Validation Scientist

CSL Limited; City of Melbourne; On-site; AUD 90,000 - 120,000; Full time

Job summary

CSL Behring Broadmeadows is seeking a QC Validation Analytical Scientist to join our Quality Control Validation team. You will develop and execute analytical validation studies and support lifecycle management of methods for biopharmaceutical products, ensuring GMP compliance.

You will design experiments, coordinate testing, review data, and contribute to investigations, deviations, and regulatory inspections in a highly regulated environment.

Qualifications

• Bachelor's degree in Biological Sciences, Chemistry, Biotechnology, Pharmacy, or related field.
• Minimum 2 years' experience in a cGMP Quality Control laboratory or equivalent postgraduate research experience.
• Experience in analytical method development, validation, qualification, and/or method transfer.
• Strong technical writing and documentation skills.
• Commitment to GMP compliance and data integrity.

Responsibilities

• Develop and execute analytical validation and investigation studies.
• Design experimental plans, coordinate testing activities, and deliver project outcomes.
• Support analytical method development, validation, qualification, transfer, and lifecycle management activities.
• Investigate deviations, method performance issues, atypical results, and other laboratory events.
• Review and verify scientific data, reports, protocols, and technical documentation.
• Prepare and maintain SOPs, test procedures, validation protocols, and study reports.
• Support regulatory inspections, audits, and quality investigations.
• Coordinate activities across multiple stakeholders to ensure project deliverables are achieved on time.
• Provide scientific support, technical expertise, and training to colleagues as required.
• Contribute to continuous improvement initiatives that enhance laboratory performance and compliance.

Skills

Analytical method development

Analytical method validation

Method transfer

GMP compliance

Data analysis

Scientific writing

Cross-functional collaboration

LIMS experience

Education

Bachelor's degree in Biological Sciences, Chemistry, Biotechnology, Pharmacy or related

Tools

HPLC

GC

Job description

An exciting opportunity has become available for a QC Validation Analytical Scientist to join our Quality Control Validation team.

Reporting to the Manager, QC Validation, you will play a key role in the development, execution, and delivery of analytical validation studies, investigations, and method lifecycle activities that support the manufacture and release of life‑saving biopharmaceutical products.

This role is suited to an analytical scientist who enjoys scientific problem solving, experimental design, cross‑functional collaboration, and working in a highly regulated GMP environment. You will contribute to validation projects, method transfers, investigation activities, and continuous improvement initiatives while ensuring compliance with regulatory and quality requirements.

This is an onsite role that will be based in Broadmeadows.

Key Responsibilities:

Develop and execute analytical validation and investigation studies.

Design experimental plans, coordinate testing activities, and deliver project outcomes.

Support analytical method development, validation, qualification, transfer, and lifecycle management activities.

Investigate deviations, method performance issues, atypical results, and other laboratory events.

Review and verify scientific data, reports, protocols, and technical documentation.

Prepare and maintain SOPs, test procedures, validation protocols, and study reports.

Support regulatory inspections, audits, and quality investigations.

Coordinate activities across multiple stakeholders to ensure project deliverables are achieved on time.

Provide scientific support, technical expertise, and training to colleagues as required.

Contribute to continuous improvement initiatives that enhance laboratory performance and compliance.

About You

You are a scientifically curious and detail‑oriented professional who enjoys applying analytical and problem‑solving skills in a dynamic quality environment. You are comfortable working both independently and collaboratively while managing competing priorities and project timelines.

Bachelor’s degree in Biological Sciences, Physical Sciences, Chemistry, Biotechnology, Pharmacy, or a related scientific discipline.

Minimum 2 years' experience in a cGMP Quality Control laboratory or equivalent postgraduate research experience.

Experience in analytical method development, validation, qualification, and/or method transfer.

Understanding of analytical method lifecycle management.

Experience supporting investigations, root cause analysis, and data review activities.

Strong technical writing and documentation skills.

Excellent communication and stakeholder management capabilities.

Experience with LIMS, electronic quality systems, and controlled documentation systems is advantageous.

Experience working with biological or biopharmaceutical products is highly desirable.

Strong scientific and technical capability.

Excellent problem‑solving and analytical skills.

Ability to manage multiple priorities and projects simultaneously.

Commitment to GMP compliance, quality, and data integrity.

A collaborative approach and willingness to support team success.

Passion for continuous improvement and innovation.

Why Join Us?

Work in a world‑class biopharmaceutical manufacturing environment.

Contribute to products that improve and save lives globally.

Join an experienced Quality Control Validation team.

Access ongoing training and professional development opportunities.

Be part of a culture focused on innovation, collaboration, quality, and patient outcomes.

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.