A global leader in animal health and biopharmaceutical manufacturing is seeking a technically skilled and quality-driven Process Validation Scientist / Senior Scientist / Process Engineer to join its Melbourne site. The company develops and manufactures advanced biological products used to support animal and human health outcomes, operating to the highest standards of GMP compliance and process excellence.

You will play a key role in validating new and modified manufacturing processes, ensuring robust process design, regulatory compliance and ongoing process control, while supporting continuous improvement across the site's bioprocessing operations.

Key Responsibilities

- Lead the design, execution and documentation of process validation activities for current product introductions and changes to existing processes

- Develop and implement continued process verification strategies to maintain control of critical process parameters

- Author and review validation protocols, reports, change controls and risk assessments

- Coordinate and execute technical trials to support process transfers and scale-up activities

- Support cleaning validation and equipment qualification for bioreactor and downstream systems,



including processes incorporating single-use technologies

- Identify and implement process optimisation opportunities

- Lead root cause analysis and corrective actions for process deviations and inefficiencies

- Develop, maintain and update GMP documentation, including SOPs, batch records, risk assessments, validation protocols, reports and validation master plans

- Develop and deliver technical training on process validation principles, GMP compliance and manufacturing best practice

Essential Skills & Experience

- Bachelor's degree in a relevant science or engineering field (Bioprocessing, Chemical Engineering, Microbiology, etc.)

- 5 years' experience in process validation within a pharmaceutical or biomanufacturing environment

- Hands-on experience with bioreactors and process validation studies

- Advanced degree or industry placement in bioprocessing desirable

- Strong understanding of GMP, regulatory standards and process validation methodologies

- Proficient in data analysis, documentation and technical writing

- Experience with real-time monitoring, Process Analytical Technology and Industry 4.0 principles

📌 Process Engineer (Melbourne)
🏢 Peritus Recruitment
📍 Melbourne