Commissioning and Qualification Manager - Melbourne, Australia


Job Description

CQV Manager – Melbourne, Australia 

Job Role
Lead the overall execution of the commissioning, qualification and validation efforts regarding initiation, budgeting, scheduling, implementation, monitoring and closure according to requirements for capital investments of facilities, utilities, equipment, analytical equipment and computerized manufacturing systems.
The Company
An American multinational consulting business with a large proportion of their work originating from the pharmaceutical and life sciences sector.

•    Develop contractual strategy and framework to lead vendors, contractors, and corresponding contracts in assigned work to deliver commissioning, qualification, and validation strategy.
•    Participate/lead regulatory surveillance and benchmarking initiatives to stay abreast of changes in regulations that affect impacted processes and to identify new ways of working and evolving technologies.
•    Assist in development and maintenance of a global centre of excellence with best practices, strategies and framework for commissioning and qualification based on current regulations, industry standards and industry practices for biopharmaceutical products.
•    Strong multi‐tasking ability in conjunction with proven organizational skills. Ability to organize assigned tasks in a high-paced environment and concurrently monitor tasks / assignments with others that may impact timely completion. Ability to effectively manage multiple tasks and activities       simultaneously.
•    Function as owners of C&Q catalog-based project playbook
•    Foster a culture of continuous improvement while focusing on operational efficiency and the elimination of “non-value added” activities.
•    Provide a positive and equitable working environment emphasizing the CSL Values: Customer Focus, Innovation, Integrity, Collaboration, and Superior Performance.
•    Complies with requirements from CSL Behring’s Safety Program, including Health and 
•    Safety mandates and OSHA requirements.
•    Completes any other duties/responsibilities assigned by senior management.

Candidate Requirements
•    Significant commissioning and qualification experience in Pharmaceutical / R&D projects
•    Advanced knowledge of pharmaceutical, manufacturing and laboratory systems and equipment
•    Experienced as a leader with direct and in-direct reports
•    Comprehension of industry and regulatory authorities regulations related to biopharmaceutical facilities

For more information

Tim Millington