Senior C&Q Principal

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

Job summary

CSL is seeking a Senior Principal for Qualification & Commissioning to oversee all C&Q activities across new and modified facilities, equipment and systems. You will lead master plans, establish GMP-compliant strategies and drive lifecycle management across CSL sites in Australia.

You will mentor teams, coordinate with project managers and engineers, and ensure readiness for regulatory inspections while aligning with global policies and quality systems.

Qualifications

• Tertiary qualification in Science or Engineering.
• 5+ years’ experience in pharmaceutical manufacturing; C&Q focus.
• Strong knowledge of cGMP and validation principles.
• Experience supporting regulatory audits/inspections (TGA, FDA).

Responsibilities

• Lead and manage all Qualification & Commissioning activities across facilities, equipment and systems from master plan to execution and handover.
• Develop and maintain C&Q Master Plans, SOPs, protocols, reports and documentation.
• Embed C&Q requirements into system design, testing, deployment and lifecycle management.
• Oversee project delivery, design reviews, testing, and post‑deployment support to meet schedules.
• Provide leadership, coaching and SME support to project teams and site personnel.
• Ensure regulatory compliance and readiness for inspections across CSL sites.

Skills

Leadership

Regulatory knowledge

Strategic thinking

Cross-functional collaboration

Education

Science or Engineering degree

Job description

The Opportunity:

The C&Q Senior Principal is responsible for overseeing all qualification and commissioning activities, including the planning, development, and execution of projects involving new and modified facilities, equipment, and processes. The role ensures a consistent site-wide approach to qualification and commissioning, develops new strategies where required, and serves as a Subject Matter Expert for the implementation of global policies and SOPs. The C&Q Senior Principal provides technical leadership to ensure compliant qualification, commissioning, of systems, equipment, and processes.

The Role:

• Lead and manage all Qualification & Commissioning (C&Q) activities across new and modified facilities, equipment, and systems, from master plan development through execution, handover, and ongoing validation support.
• Develop, maintain, and continuously improve C&Q and Validation Master Plans, methodologies, SOPs, protocols, reports, and other departmental documentation in line with global engineering and quality standards.
• Partner with Project Managers, Process Engineers, Equipment Owners, and cross-functional stakeholders to ensure C&Q requirements are embedded into system design, implementation, testing, deployment, and lifecycle management.
• Oversee project delivery for new and modified systems, including design reviews, gap assessments, resource planning, testing, implementation, reporting, post-deployment support, and achievement of project schedules and milestones.
• Provide supervisory responsibilities and technical support for projects consisting of external contractors supporting Capex, Opex, Process Improvements, Change Control management, CAPA qualification activities at the Broadmeadows Site.
• Provide leadership, coaching, training, and subject matter expertise to direct reports, project teams, and site personnel, ensuring competency, regulatory compliance, knowledge sharing, and strong collaboration across CSL sites.
• Maintain expertise in regulatory and industry requirements, promote GMP compliance, support regulatory inspections and audits, and ensure documentation, presentations, and team preparedness meet inspection expectations.
• Lead the team in alignment with CSL values, quality, safety and environmental standards, while supporting business objectives through process improvements, budget management, forecasting, cost recovery, and compliance with all applicable corporate policies and quality systems.

To be successful:

• Tertiary qualification in Science or Engineering, with demonstrated experience leading technical teams within a regulated pharmaceutical or manufacturing environment.
• Minimum 5 years’ experience in pharmaceutical manufacturing, with strong expertise in Qualification & Commissioning (C&Q), Process Validation, and/or Cleaning Validation.
• Strong working knowledge of cGMP requirements, validation principles, and current industry standards and guidance related to process and cleaning validation.
• Direct experience supporting regulatory audits and inspections, with a sound understanding of TGA, FDA, and broader pharmaceutical regulatory requirements.
• Proven analytical and problem-solving capability, with the ability to think strategically from a systems perspective while effectively navigating complexity and ambiguity.
• Strong leadership, communication, collaboration, and stakeholder management skills, with the ability to mentor teams, influence at all levels, manage competing priorities, and deliver successful outcomes in a dynamic environment.