C&Q Principal

CSL; Melbourne; On-site; AUD 180,000 - 240,000; Full time

Job summary

CSL seeks a C&Q Principal to provide technical leadership for commissioning and qualification across new and modified facilities, utilities, equipment, systems, and processes. The role serves as the site's SME for C&Q, ensuring compliance with regulatory requirements, global quality standards, and site procedures.

You will lead the development, planning, execution, and continuous improvement of qualification strategies while driving a risk-based lifecycle approach and partnering with

Qualifications

• Experience leading commissioning and qualification activities in GMP-regulated environments.
• Knowledge of cGMP requirements and validation lifecycle principles.
• Experience supporting regulatory inspections and audits (e.g., TGA, FDA).

Responsibilities

• Lead development, execution, and lifecycle management of commissioning and qualification activities.
• Develop and maintain Qualification Master Plans aligned with global standards.
• Serve as site SME for C&Q, guiding strategies and regulatory requirements.
• Partner with project teams to embed qualification requirements across design and handover phases.
• Create and approve qualification documentation including protocols and reports.
• Identify and mitigate GMP and quality risks; escalate deviations and gaps.
• Maintain qualification systems to support regulatory audits and inspections.

Skills

Leadership

Regulatory compliance

GMP knowledge

Quality systems

Risk assessment

Education

Bachelor's degree in Engineering, Pharmaceutical Science, Biotechnology, Chemistry, or related technical discipline

Job description

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 efficient 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.