Senior Process Engineer Melbourne

biotech; City of Melbourne; On-site; AUD 90,000 - 130,000; Full time

Job summary

biotech is seeking a senior process engineering professional to provide technical leadership for process technologies across capital projects and manufacturing support activities. The role focuses on developing clear, measurable process design requirements aligned with regulatory expectations and project goals.

You will review data, tech transfer packages, and manufacturing requirements to inform equipment and system design decisions while leading risk-based assessments and CQV activities to

Qualifications

• Experience drafting and executing CQV protocols.
• Developing SOPs and validation & quality policies.
• Strong experience creating and maintaining CQV policies and processes.
• Familiar with cGMPs and CFR21 Part 11 guidelines.
• Exposure to validation systems, including Kneat.

Responsibilities

• Provide technical leadership in development and implementation of process technologies across capital projects and manufacturing support activities.
• Develop and maintain process design requirements aligned with project objectives and regulatory expectations.
• Review process data, tech transfer packages, and manufacturing requirements to support design decisions.
• Lead technical evaluations and risk-based assessments to identify improvement opportunities and mitigate risks.
• Support design, commissioning, qualification, and validation of process systems to meet performance and compliance.
• Provide SME during design reviews, troubleshooting, investigations, and process optimisation initiatives.
• Ensure changes are assessed, documented, and implemented through quality and change management systems.
• Facilitate risk assessments and process hazard analyses to support project delivery.

Skills

CQV protocols

Process validation

Risk assessments

Tools

Kneat

Job description

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.