Senior Process Engineer - GMP, CQV & Tech Transfer

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

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