Ms&t Principal

3 days ago

Melbourne, Australia CSL Full time

The Opportunity

The Process Engineering function at CSL Behring is recruiting for a Manufacturing Science & Technology (MS&T) Principal (Engineer or Scientist) to join our dynamic team at the Broadmeadows site. This exciting full-time permanent role will oversee time-important frontline technical support within the bulk space to our life-saving parenteral manufacturing operations and strategic project execution.

The Role

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

- Identify pro-active indicators to measure process performance and improve the process to optimise and realise quality and/ or yield opportunities
- Inform and develop the process control strategy based on scientific understanding and principals
- Deliver MS&T proactive and re-active improvements across bulk platforms
- Collaborating within the 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 main partner functions (Value Stream, Project Delivery, Quality Assurance etc.)
- Build process understanding and working with global counterparts and colleagues to identify synergies across multiple facilities
- Own and interpret KPI's to ensure the process is reliably and repeatably producing
- Identify ways to test theories and prove cause using data, internal and external expertise and lab based capabilities
- Assure compliance with safety and regulatory requirements during all phases of MS&T activities

Your experience
- MS/MBA/BS/BA in Engineering or Life Sciences
- 5+ years' experience in Science/ Engineering within a pharmaceutical manufacturing operation or in a pharmaceutical operation
- 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)

How to Apply

LI-Onsite

**Our Benefits**:
We encourage you to make your well-being a priority. It’s important and so are you. Learn more about how we care at CSL.

**About CSL Behring**:
CSL Behring is a global leader in developing and delivering high-quality medicines that treat people with rare and serious diseases. Our treatments offer promise for people in more than 100 countries living with conditions in the immunology, hematology, cardiovascular and metabolic, respiratory, and transplant therapeutic areas. Learn more about CSL Behring.

**We want CSL to reflect the world around us**:
As a global organisation with employees in 35+ countries, CSL embraces diversity and inclusion. Learn more about Diversity & Inclusion at CSL.

**Do work that matters at CSL Behring**:

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