Senior Process Engineer - CQV & Validation Lead

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

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