Key Responsibilities

Provide technical leadership in the development and implementation of process technologies across capital projects, operational improvements, and manufacturing support activities. Develop and maintain process design requirements, ensuring they are clearly defined, measurable, and aligned with project objectives and regulatory expectations. Review and interpret process data, technology transfer packages, and manufacturing requirements to support equipment and system design decisions. Partner with project, operations, quality, and engineering teams to ensure process solutions are effectively integrated into manufacturing environments. Lead technical evaluations and risk-based assessments to identify process improvement opportunities and mitigate operational risks. Support the design, commissioning, qualification, and validation of new and modified process systems to ensure they meet performance and compliance requirements. Provide subject matter expertise during design reviews, troubleshooting activities, investigations, and process optimisation initiatives. Ensure process changes are appropriately assessed, documented,



and implemented through established quality and change management systems. Facilitate risk assessments, FMEAs, and process hazard analyses to support project delivery. Ensure compliance with quality, validation, engineering, and regulatory standards. Partner with cross-functional teams to resolve technical issues and drive continuous improvement initiatives.

Requirements

Proficient in authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents. Proficient in developing SOPs, final reports and validation & quality policies. Strong experience developing and executing CQV protocols. Strong experience creating and maintaining CQV policies and processes. Has good understanding and complies to cGMPs and CFR21 Part 11 guidelines. Exposure to digital and paper-based validation systems, including platforms such as Kneat. Background in Pre-filled syringe (PFS) technology, Vial Filling, Sterile Filtration, Bulk Product, Recent Product Initiative (NPI) manufacturing, Plasma Manufacturing.

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📌 Senior Process Engineer Melbourne
🏢 biotech
📍 Melbourne