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 setting.
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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 new 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