Commissioning And Qualification Principal Lead

Your Role

The Process Engineering function at CSL Behring is recruiting for a Commissioning and Qualification (C&Q) Principal (Engineer or Scientist) to join our team at the Broadmeadows site. This exciting full-time permanent role is pivotal to ensuring the successful Commissioning and Qualification of new and modified equipment and facilities within the pharmaceutical manufacturing environment.

The successful candidate will apply fundamental scientific and engineering knowledge to the strategic planning and implementation of Commissioning and Qualification of complex equipment and systems on site.

You will work with a broad range of local and global counterparts and functions as diverse as Manufacturing, Project Delivery, Quality, and Regulatory Affairs alongside and as a representative of the Process Engineering (PE) organisation.

Your Responsibilities

Reporting to the Associate Director, C&Q Site Lead, you will:

• Developing comprehensive strategies for the implementation of new and improved equipment and systems
• Building, facilitating and maintaining execution programs for successful project delivery
• Reviewing and implementation of best practices and standardized methodologies to enhance efficiency and effectiveness across projects.
• Evaluating existing Commissioning and Qualification processes and identify opportunities for improvement.
• Establishing partnerships and collaborations with internal and external stakeholders incl Global CSL Network, industry organizations, and academic institutions, to stay abreast of emerging trends, technologies, and best practices in Commissioning and Qualification.
• Collaborating within the PE organisation to prioritise work, identify the highest value improvements and facilitate scoping and execution of implementation within internal PE functions (Manufacturing Science & Technology (MS&T), Process Technology (PT), Validation, Stability & Execution Systems) and across key partner functions (Value Stream, Project Delivery, Quality Assurance)
• Assisting in departmental planning, performance and process optimization by identifying goals, objectives, and key performance indicators aligned with organizational priorities.
• Implementing and maintaining performance metrics and monitoring mechanisms to track the progress, completion status and effectiveness of Commissioning and Qualification as a function of project delivery.
• Assuring compliance with safety and regulatory requirements during all phases of project delivery and C&Q activities.

Your Experience

• Bachelors in Engineering, Business Administration or Life Sciences
• 5+ years experience in Science/ Engineering within a pharmaceutical manufacturing operation or in a pharmaceutical operation
• Functional knowledge of cGMPs and manufacturing operations in FDA regulated facility
• Knowledge of C&Q, Validation, CMC and facility regulatory submission requirements
• Good understanding of project management principles and project lifecycle phases with experience preferred
• Demonstrated experience in complex cross functional project implementation
• Demonstrated ability to thrive in cross-functional, multicultural and international teams

To Apply

Please submit your application including a cover letter and resume by Monday 6th May 2024.

Apply now to join a world-class pharmaceutical organisation that is continuing to grow and with a high-achieving, positive and diverse team!

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