A leading global pharmaceutical and biotechnology manufacturing organisation.
Seeking a Process Validation Scientist / Senior Scientist / Process Engineer to join their Melbourne-based technical operations team.
2 years fixed term contract with potential to go permanent.
Work closely with Manufacturing, Quality, Engineering and Regulatory teams in a highly regulated GMP setting.

About the company/role:
A leading global pharmaceutical and biotechnology manufacturing organisation.
Seeking a Process Validation Scientist / Senior Scientist / Process Engineer to join their Melbourne-based technical operations team.
2 years fixed term contract with potential to go permanent.
Work closely with Manufacturing, Quality, Engineering and Regulatory teams in a highly regulated GMP workplace.
Melbourne location.

Duties:

Reporting to the Technical Manager, your duties may include:
Leading process validation activities for new products and changes to existing manufacturing processes.
Developing and executing validation protocols, reports, risk assessments and change controls.
Supporting continued process verification and process monitoring programs.
Coordinating process transfer, technical trial and scale-up activities.
Supporting equipment qualification,



cleaning validation and implementation of new technologies.
Investigating process deviations, performing root cause analysis and implementing corrective actions.
Preparing and maintaining GMP documentation including SOPs, validation protocols, reports and validation plans.
Driving continuous improvement initiatives to enhance process performance and product quality.

About you:
Bachelor's degree in Science, Biotechnology, Microbiology, Bioprocessing, Chemical Engineering or a related discipline.
Previous experience in process validation within pharmaceutical, biotechnology or biomanufacturing environments.
Robust understanding of GMP requirements, validation principles and regulatory expectations.
Experience authoring technical documentation including validation protocols, reports, risk assessments and change controls.
Exposure to process improvement, process transfer, equipment qualification or manufacturing support activities.
Excellent communication, stakeholder management and technical writing skills.
Strong problem-solving skills with the ability to work collaboratively across multiple departments.
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📌 Process Validation Scientist Melbourne
🏢 Evolve Scientific
📍 Melbourne