QC Validation Scientist

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

Job summary

CSL Vifor is seeking a QC Validation Analytical Scientist to join the Quality Control Validation team in Australia. You will develop, execute, and deliver analytical validation studies, investigations and method lifecycle activities that support biopharmaceutical manufacture and release.

You will contribute to validation projects, method transfers, investigation activities, and continuous improvement initiatives while ensuring compliance with regulatory and quality requirements.

Qualifications

• Bachelor’s degree in Biological Sciences, Physical Sciences, Chemistry, Biotechnology, Pharmacy, or 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 working with biological or biopharmaceutical products is highly desirable.

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 thinking

Stakeholder management

Education

Bachelor's degree in Biological Sciences or related

Tools

LIMS

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.