Senior C&Q Principal

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

Job summary

CSL Behring in Broadmeadows, VIC is seeking a C&Q Senior Principal to lead qualification and commissioning across new and modified facilities, equipment, and systems. You will develop strategies, ensure global policy alignment, and provide site-wide technical leadership.

You will partner with project managers and engineers, manage delivery, and mentor teams while upholding GMP and regulatory expectations. This permanent full-time role offers a pathway to influence at scale within CSL Behring.

Qualifications

• Tertiary qualification in Science or Engineering.
• Minimum 5 years’ experience in pharmaceutical manufacturing with expertise in C&Q, Process Validation or Cleaning Validation.
• Strong knowledge of cGMP requirements and validation principles.
• Direct experience supporting regulatory audits and inspections (TGA, FDA) and related regulatory requirements.

Responsibilities

• 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 standards.
• Partner with Project Managers, Process Engineers, Equipment Owners, and cross-functional stakeholders to embed C&Q requirements into system design and lifecycle management.
• Oversee project delivery for new and modified systems, including design reviews, resource planning, testing, implementation, and milestone achievement.
• Provide supervisory responsibilities and technical support for projects with external contractors, CAPEX/OPEX, and Change Control activities.
• Lead and mentor direct reports and project teams to ensure competency, regulatory compliance, and cross-site collaboration.
• Maintain expertise in regulatory requirements and promote GMP compliance, inspections readiness, and documentation quality.

Skills

C&Q

Process Validation

Cleaning Validation

Regulatory Audits

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.

We are recruitinga C&Q Senior Principal to join ourteam at our manufacturing facility at 189–209 Camp Road, Broadmeadows, VIC 3047.

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.

This is a Permanent full-time position.

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.

Application Period: Applications open on 23rd of October and closes on 23rd of November 2026.

About CSL Behring

CSL Behring is a global biotherapeutics leader driven by our promise to save lives. Focused on serving patients’ needs by using the latest technologies, we discover, develop and deliver innovative therapies for people living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. We use three strategic scientific platforms of plasma fractionation, recombinant protein technology, and cell and gene therapy to support continued innovation and continually refine ways in which products can address unmet medical needs and help patients lead full lives.

CSL Behring operates one of the world’s largest plasma collection networks, CSL Plasma. Our parent company, CSL, headquartered in Melbourne, Australia, employs 32,000 people, and delivers its lifesaving therapies to people in more than 100 countries.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

Equal Opportunity Employer

CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.