C&Q Principal — GMP Commissioning & Qualification Leader

CSL; Broadmeadows; Presencial; AUD 200 000 - 260 000; Tempo integral

Resumo da oferta

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

Qualificações

• 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.

Responsabilidades

• 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.

Conhecimentos

Commissioning & Qualification

GMP-regulated manufacturing

Regulatory inspections & audits

cGMP knowledge

Analytical & problem-solving

Stakeholder engagement & communication

Organisational skills

Formação académica

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

Descrição da oferta de emprego

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