Process Validation Scientist
- Lead process validation activities for new products and changes to existing manufacturing processes.
- Develop and execute validation protocols, reports, risk assessments and change controls.
- Drive continuous improvement initiatives to enhance process performance and product quality.
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.
Apply!
If you think this could be the role for you then please apply now! Please send us a cover letter AND a detailed resume in WORD format (PDFs can be corrupted / not processed).
Or, if you have any questions, please contact Priyanka on ************.
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