Commissioning & Qualification Lead

We are expanding in Australia; a position is available for Commissioning & Qualification Lead at CSL Behring, Broadmeadows. Reporting to the Head of Project Engineering, you will provide strategic, technical and people leadership for an integrated site C&Q; function responsible for project commissioning and qualification activities and ongoing lifecycle requalification programs.

Responsibilities

- Leading a team of approximately 25 engineering professionals and being accountable for defining and implementing the site's C&Q; strategy.
- Ensuring facilities, utilities, equipment and processes are commissioned, qualified and maintained in a compliant state throughout their lifecycle.
- Leading the evolution of CSL’s C&Q; model and creating a hybrid delivery model that leverages engineering organizations to provide industry best practice, additional resource support and scalable solutions.
- Leading, coaching and developing a high‑performing site C&Q; organization, fostering accountability, collaboration, technical excellence and continuous improvement.
- Acting as the senior C&Q; subject‑matter expert and bearing ultimate responsibility for end‑to‑end C&Q; delivery from design through commissioning, qualification, start‑up, handover and ongoing lifecycle management.
- Serving as the key interface between Engineering, Quality,



Operations, Validation, Regulatory, Maintenance, external engineering partners and global C&Q;/validation functions.
- Embedding digitally enabled C&Q; practices, including adoption of ASTM E2500 principles, use of standard methods and templates, leveraging vendor documentation where appropriate, and effective use of digital validation platforms such as Kneat.

Qualifications

- Demonstrated experience leading commissioning, qualification, validation or lifecycle compliance activities in a cGMP environment.
- Advanced knowledge of cGMP, TGA, FDA, PIC/S and relevant industry guidance for commissioning, qualification, validation and lifecycle compliance.
- Knowledge of ASTM E2500 principles is desirable.
- Leadership experience in leading a function, change management and a demonstrated history in delivery of hybrid work solutions.
- Stakeholder engagement and influencing skills; the ability to build credibility across technical teams, senior leadership and global functions.
- A bachelor’s degree in Engineering, Science or a related discipline.

Equal Chance Employer

CSL is an Equal Opportunity Employer. We provide reasonable accommodation to applicants with disabilities. CSL Global Privacy Notice for Job Applicants and Candidates.

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📌 Commissioning & Qualification (C&Q) Lead (City of Hume)
🏢 Csl Plasma
📍 City of Hume