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Commissioning and Qualification

3 weeks ago

Broadmeadows, Australia CSL Behring Full time

**Your Role**

The Process Engineering department at CSL Behring is recruiting for a **Commissioning and Qualification (C&Q) Principal**(Engineer or Scientist) to join our dynamic 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, facilities, and utilities, within the pharmaceutical manufacturing environment.

You will work with a broad range of local and global counterparts and functions as diverse as Manufacturing, Project Delivery (PD) incl. Project Management Operations, Quality, and Regulatory Affairs alongside and as a pivotal representative of the Process Engineering (PE) organisation. You will also closely work and partner with the rest of the PE organisation, both globally and at the site level, including Process Technology (PT), Manufacturing Science and Technology (MS&T), Execution Systems, Validation and Stability.

**Your Responsibilities**:
Reporting to the **Associate Director, C&Q Site Lead**, your responsibilities will include:

- Developing comprehensive strategies for the implementation of complex systems and process technology, including highly automated processing equipment, facilities, and utilities.
- Building, facilitating and maintaining execution programs based on the qualification strategies for the successful implementation of engineering projects and continuous improvement initiatives.
- Reviewing and implementation of best practices and standardized methodologies to enhance efficiency and effectiveness across engineering projects and continuous improvement initiatives.
- 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, for example Manufacturing Science & Technology (MS&T), Process Technology (PT), Validation, Stability, and Execution Systems, and across key partner functions (Manufacturing Operations / Value Stream, Project Delivery, Quality Assurance etc.)
- 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**
- MS/ BS/BA in Engineering or Life Sciences preferred or local equivalent
- 5+ years’ experience within Commissioning and Qualification in pharmaceutical manufacturing or a highly regulated industry.
- Ideally 2+ years’ experience in project, production or process engineering within pharmaceutical manufacturing or a highly regulated manufacturing industry preferred.
- 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
- Strong resourcefulness, drive, communication, collaboration, and conflict management skills
- Dynamic, adaptable, innovate and resilient
- Demonstrated ability to thrive in cross-functional, multicultural and international teams
- Good problem-solving skills, including ability to learn technical skills on the fly and to lead problem-solving initiatives to a timely completion.

**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**: