Job Description
Melbourne, Australia
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We are seeking a Senior Process Engineer to support ongoing process development within a GMP - regulated environment . This role will play a key part in defining and managing process requirements for pharmaceutical projects, supporting system design, technology transfer, risk assessments, and compliance activities to ensure successful project execution and operational readiness.
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Key Responsibilities
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Provide technical leadership in the development and implementation of process technologies across capital projects, operational improvements, and manufacturing support activities.
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Develop and maintain process design requirements, ensuring they are clearly defined, measurable, and aligned with project objectives and regulatory expectations.
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Review and interpret process data, technology transfer packages, and manufacturing requirements to support equipment and system design decisions.
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Partner with project, operations, quality, and engineering teams to ensure process solutions are effectively integrated into manufacturing environments.
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Lead technical evaluations and risk-based assessments to identify process improvement opportunities and mitigate operational risks.
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Support the design, commissioning, qualification, and validation of new and modified process systems to ensure they meet performance and compliance requirements.
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Provide subject matter expertise during design reviews, troubleshooting activities, investigations, and process optimisation initiatives.
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Ensure process changes are appropriately assessed, documented, and implemented through established quality and change management systems.
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Facilitate risk assessments, FMEAs, and process hazard analyses to support project delivery.
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Ensure compliance with quality, validation, engineering, and regulatory standards.
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Partner with cross-functional teams to resolve technical issues and drive continuous improvement initiatives.
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Requirements
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Requirements
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Proficient in authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.
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Proficient in developing SOPs, final reports and validation & quality policies.
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Solid experience developing and executing CQV protocols.
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Strong experience creating and maintaining CQV policies and processes.
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Has good understanding and complies to cGMPs and CFR21 Part 11 guidelines.
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Exposure to digital and paper-based validation systems, including platforms such as Kneat .
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Background in Pre-filled syringe (PFS) technology, Vial Filling, Sterile Filtration, Bulk Product, New Product Initiative (NPI) manufacturing, Plasma Manufacturing
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📌 Senior Process Engineer Melbourne (Victoria)
🏢 PSC Biotech
📍 Victoria