C&Q Principal

CSL; Broadmeadows; On-site; AUD 200,000 - 260,000; Full time

Job summary

CSL Behring Australia seeks a C&Q Principal to provide technical leadership across commissioning and qualification for new and modified facilities, utilities, equipment, and processes. You will serve as the site SME for C&Q, ensuring compliance with regulatory requirements, global quality standards, and site procedures.

You will lead development and execution of qualification strategies, work with Engineering, Manufacturing, Quality, Validation, and Global teams, and drive risk-based lifecycle

Qualifications

• Bachelor’s degree in Engineering, Pharmaceutical Science, Biotechnology, Chemistry, or a related technical discipline.
• Proven experience leading commissioning/qualification or engineering activities in GMP environments.
• Knowledge of cGMP, validation lifecycles, and equipment/process qualification standards.

Responsibilities

• Lead development, execution, and lifecycle management of commissioning and qualification for new or modified facilities and processes.
• Develop and maintain Qualification Master Plans aligned with GMP and project objectives.
• Act as site SME for C&Q, guiding qualification strategies and regulatory compliance.
• Collaborate with project teams to embed qualification requirements across design, installation, testing, and handover.
• Prepare, review, and approve qualification docs including protocols and reports.
• Identify and mitigate GMP and quality risks; escalate deviations and issues.
• Support regulatory inspections and maintain audit readiness.

Skills

Commissioning & Qualification

GMP-regulated manufacturing

Regulatory inspections & audits

cGMP knowledge

Analytical & problem-solving

Stakeholder engagement & communication

Organisational skills

Education

Bachelor’s degree in Engineering, Pharmaceutical Science, Biotechnology, Chemistry, or a 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 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.

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.