Commissioning & Qualification (C&Q) Lead

CSL

1d•Onsite

About The Position

CSL Behring Australia is undergoing extensive and positive change as we expand and grow. In addition to contributing to Australia's export economy, CSL has invested and continues to invest in substantial new manufacturing facilities to support CSL's global strategy and provide the network with crucial supply of finished / intermediates sourced from our Australian facilities. Due to an internal move, a position is available for a Commissioning & Qualification (C&Q) Lead to join our team 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 both project commissioning and qualification activities and ongoing lifecycle requalification programs.

Requirements

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 demonstrated history in delivery of hybrid work solutions
Stakeholder engagement and influencing skills; ability to build credibility across technical teams, senior leadership and global functions
A Bachelors degree in Engineering, Science or related discipline.

Responsibilities

Leading a team of approximately 25 engineering professionals, you will be 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.
Lead the evolution of CSL’s C&Q model and create a hybrid delivery model leveraging engineering organisations to provide industry best practice, additional resource support and scalable solutions
Lead, coach and develop a high-performing site C&Q organisation, fostering accountability, collaboration, technical excellence and continuous improvement
Act as the senior C&Q Subject Matter Expert and ultimate responsibility for end-to-end C&Q delivery from design through commissioning, qualification, start-up, handover and ongoing lifecycle management
Key interface between Engineering, Quality, Operations, Validation, Regulatory, Maintenance, external engineering partners and global C&Q / validation functions
Accountable for embedding of 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.