The Opportunity

The C&Q; Principal is responsible for providing technical leadership and oversight across all commissioning, qualification, and associated with new and modified facilities, utilities, equipment, systems, and manufacturing processes. The role serves as the site's subject matter expert (SME) for C&Q;, ensuring compliance with regulatory requirements, global quality standards, and site procedures.

The Opportunity

The C&Q; Principal is responsible for providing technical leadership and oversight across all commissioning, qualification, and associated with new and modified facilities, utilities, equipment, systems, and manufacturing processes. The role serves as the site's subject matter expert (SME) for C&Q;, ensuring compliance with regulatory requirements, global quality standards, and site procedures. The C&Q; Principal leads the development, planning, execution, and continuous improvement of commissioning and qualification strategies while driving a risk-based approach to lifecycle management. This position partners with Engineering, Manufacturing, Quality, Validation, and Global Technical teams to ensure projects are delivered safely, efficiently, and in compliance with GMP requirements.

The Role

- Lead the development, execution, and lifecycle management of commissioning and qualification, activities for new and modified facilities, equipment, utilities, systems, and processes.
- Develop, maintain, and continuously improve Qualification Master Plans, ensuring alignment with global engineering standards, GMP requirements, and project objectives.
- Serve as the site Subject Matter Expert (SME) for C&Q;, providing technical guidance on qualification strategies, regulatory requirements, and implementation of global policies, procedures, and standards.
- Partner with project teams and system owners to ensure qualification requirements are embedded throughout design,



installation, testing, commissioning, and operational handover phases.
- Author, review, and approve qualification documentation including protocols, reports, risk assessments, SOPs, commissioning plans.
- Identify, assess, and mitigate GMP, compliance, and operational risks, ensuring timely escalation, investigation, and resolution of deviations, gaps, and quality concerns.
- Collaborate with Engineering, Validation, Manufacturing, Quality, R&D;, QC, and Project Delivery teams to deliver compliant and productive project outcomes while driving continuous improvement initiatives.
- Maintain inspection readiness by ensuring qualification systems and documentation remain current, supporting regulatory audits and inspections, and promoting adherence to applicable GMP and quality requirements.

To be successful
- Bachelor's degree in Engineering, Pharmaceutical Science, Biotechnology, Chemistry, or a related technical discipline, with significant experience in GMP-regulated manufacturing environments.
- Demonstrated experience leading and executing commissioning, qualification, or engineering activities within the pharmaceutical, biotechnology, or related regulated industries.
- Strong knowledge of cGMP requirements, validation lifecycle principles, and industry standards relating to equipment, process, cleaning, and facility qualification.
- Experience supporting regulatory inspections and audits, with a sound understanding of TGA, FDA, and other applicable regulatory expectations.
- Proven analytical and problem-solving skills, with the ability to evaluate complex systems, assess risk, and translate technical requirements into practical solutions.
- Excellent communication, stakeholder engagement, and organisational skills, with the ability to influence cross-functional teams, manage competing priorities, and provide technical mentoring and guidance.

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📌 C&Q Principal (Melbourne)
🏢 CSL
📍 Melbourne