Process Validation Scientist

• 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 environment.

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 environment.
• 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.
• Strong 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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