Process Validation Scientist

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 [03 9040 1630](tel:03 9040 1630).

With over 90 years' combined experience, NES Fircroft (NES) is proud to be the world's leading engineering staffing provider spanning the Oil & Gas, Power & Renewables, Chemicals, Construction & Infrastructure, Life Sciences, Mining and Manufacturing sectors worldwide. With more than 80 offices in 45 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. We offer contractors far more than a traditional recruitment service, supporting with everything from securing visas and work permits, to providing market-leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients.