Job Description
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A leading global pharmaceutical and biotechnology manufacturing organisation.
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Seeking a Process Validation Scientist / Senior Scientist / Process Engineer to join their Melbourne-based technical operations team.
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2 years fixed term contract with potential to go permanent.
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Work closely with Manufacturing, Quality, Engineering and Regulatory teams in a highly regulated GMP environment.
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About the company/role:
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A leading global pharmaceutical and biotechnology manufacturing organisation.
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Seeking a Process Validation Scientist / Senior Scientist / Process Engineer to join their Melbourne-based technical operations team.
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2 years fixed term contract with potential to go permanent.
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Work closely with Manufacturing, Quality, Engineering and Regulatory teams in a highly regulated GMP environment.
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Melbourne location.
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Duties:
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Reporting to the Technical Manager, your duties may include:
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Leading process validation activities for current products and changes to existing manufacturing processes.
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Developing and executing validation protocols, reports, risk assessments and change controls.
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Supporting continued process verification and process monitoring programs.
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Coordinating process transfer, technical trial and scale-up activities.
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Supporting equipment qualification, cleaning validation and implementation of new technologies.
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Investigating process deviations, performing root cause analysis and implementing corrective actions.
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Preparing and maintaining GMP documentation including SOPs, validation protocols, reports and validation plans.
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Driving continuous improvement initiatives to enhance process performance and product quality.
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About you:
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Bachelor's degree in Science, Biotechnology, Microbiology, Bioprocessing, Chemical Engineering or a related discipline.
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Previous experience in process validation within pharmaceutical, biotechnology or biomanufacturing environments.
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Strong understanding of GMP requirements, validation principles and regulatory expectations.
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Experience authoring technical documentation including validation protocols, reports, risk assessments and change controls.
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Exposure to process improvement, process transfer, equipment qualification or manufacturing support activities.
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Excellent communication, stakeholder management and technical writing skills.
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Strong problem-solving skills with the ability to work collaboratively across multiple departments.
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📌 Process Validation Scientist (Victoria)
🏢 Evolve Scientific
📍 Victoria