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 E**** 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 E**** 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.
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📌 Commissioning & Qualification (C&Q) Lead (Victoria)
🏢 Csl Plasma
📍 Victoria