Senior Process Engineer Melbourne

PSC Biotech® Corporation; City of Melbourne; On-site; AUD 120,000 - 180,000; Full time

Job summary

PSC Biotech Corporation in Melbourne, Australia, is seeking a Senior Process Engineer to support process development in a GMP-regulated environment. You will define and manage process requirements for pharmaceutical projects, support system design, technology transfer, risk assessments, and compliance to ensure successful project execution.

You will lead CQV-related activities, author DQ/FAT/SAT/IQ/OQ/PQ/PV documents, develop SOPs, and collaborate with project teams to deliver robust, compliant

Qualifications

• Experience authoring and executing DQ, FAT, SAT, IQ, OQ, PQ, and PV documents.
• Developing SOPs, final reports, and validation & quality policies.
• Strong cqv protocol development and execution experience.
• Experience creating and maintaining CQV policies and processes.
• Understanding of cGMPs and CFR21 Part 11 guidelines.
• Exposure to validation platforms such as Kneat.
• Background in PFS, vial filling, sterile filtration, bulk product and NPI manufacturing.

Responsibilities

• Provide technical leadership across capital projects, ops, and manufacturing support.
• Develop and maintain process design requirements aligned with regulatory expectations.
• Review process data, transfer packages, and requirements to support equipment design.
• Partner with project, operations, quality, and engineering teams for integrated solutions.
• Lead risk-based assessments to identify improvement opportunities and mitigate risks.
• Support design, commissioning, qualification, and validation of process systems.
• Provide SME during design reviews, investigations, and process optimisation initiatives.
• Ensure changes are assessed, documented, and controlled via quality systems.
• Facilitate FMEAs and process hazard analyses for project delivery.
• Ensure compliance with quality, validation, engineering, and regulatory standards.
• Collaborate with cross-functional teams to drive continuous improvement.

Skills

Process engineering

CQV executions

Regulatory compliance

Risk assessments

Documentation control

Cross-functional collaboration

GMP knowledge

Tools

Kneat

Job description

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.

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, New Product Initiative (NPI) manufacturing, Plasma Manufacturing