MS&T Fill & Finish Value Stream Lead

The Opportunity

The Process Engineering function at CSL Behring is recruiting for a Manufacturing Science & Technology (MS&T) Filling Value Stream Lead (Engineer or Scientist) to join our dynamic team at the Broadmeadows site. This exciting full-time permanent role will lead time-important frontline technical support within the filling production space and develop in partnerships the MS&T strategy within the Fill & Finish space in support of our life-saving parenteral manufacturing operations and strategic project execution.

You will apply fundamental scientific and engineering knowledge to the design, implementation and life cycle management of complex process and technology.

You will work with a broad range of local and global counterparts spanning three continents and functions as diverse as Manufacturing, Operational Analytics, Engineering, Quality, Technical Transfer, Validation, Research & Development and Regulatory Affairs.

The Role

Reporting to the Director, MS&T Site Lead, your responsibilities will include:

• Identifying key pro-active indicators to measure process performance across the fill and finish value stream and adjust, improve or update the process to optimise and realise quality and/ or yield opportunities

• Delivering day to day prioritisation of MS&T re-active support across the fill and finish value stream to manage workload

• Supporting the development of MS&T fill and finish value stream strategy in partnership with the MS&T site lead and stakeholders to plan and prioritise proactive improvements

• Developing processes for the fill and finish MS&T function to prioritise work, identify the highest value improvements and facilitate scoping and execution of implementation within internal PE functions (Process Technology, Qualification, Validation, Execution Systems etc.) and across key partner functions (Value Stream, Project Delivery, Quality Assurance etc.)

• Building the structure in conjunction with other MS&T value stream leads and MS&T Principals to capture and build process understanding

• Interacting with global counterparts and colleagues to identify synergies across multiple facilities in order to prioritise activities

• Owning and interpreting key value stream KPI's to ensure the process is reliably and repeatably producing

• Structuring with MS&T Principals ways to test theories and prove root cause using data, internal and external expertise and lab based capabilities

• Assuring compliance with safety and regulatory requirements during all phases of MS&T activity

• Providing cGMP compliant processes and facilities suitable for FDA and global regulatory approval

• Generating regular Product/Process performance overviews that are translated to a language relevant to stakeholders

Your skills and experience

• MS/MBA/BS/BA in Engineering or Life Sciences

• 7+ years experience in Science/ Engineering within a pharmaceutical manufacturing operation or in a pharmaceutical operation

• Experience leading matrix teams or leading teams directly desirable

• Ability to understand “the big picture” and approach problem solving in a proactive team manner

• Functional knowledge of cGMPs and manufacturing operations in FDA regulated facility

• Understanding of project management principles and project lifecycle phases

• Knowledge of Validation, CMC and facility regulatory submission requirements

• Demonstrated experience leading complex scientific investigations

• Experience with complex processes, technology and analytics

• Direct experience with regulated environments (i.e., cGMP, OSHA, EPA)

• Strong resourcefulness, drive, communication, collaboration, and conflict management skills

• Demonstrated ability to thrive in cross-functional, multicultural and international teams