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 recent 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
Robust 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