Commissioning and Qualification PrincipalThe 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.
As a C&Q Principal, the successful candidate will apply fundamental scientific and engineering knowledge to the strategic planning, implementation, and life cycle management of complex systems and process technology, including highly automated processing equipment, facilities, and utilities.
You will work with a broad range of local and global counterparts and functions as diverse as Manufacturing, Project Delivery (PD), Quality, and Regulatory Affairs, alongside and as a pivotal representative of the Process Engineering (PE) organisation.
Responsibilities: 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 implementing best practices and standardized methodologies to enhance efficiency and effectiveness across engineering projects and continuous improvement initiatives.Evaluating existing commissioning and qualification processes and identifying opportunities for improvement.Establishing partnerships and collaborations with internal and external stakeholders, including the 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 prioritize work, identify the highest value improvements, and facilitate scoping and execution of implementation within internal PE functions.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.Qualifications: 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 facilities.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, innovative, and resilient.Demonstrated ability to thrive in cross-functional, multicultural, and international teams.Good problem-solving skills, including the ability to learn technical skills on the fly and to lead problem-solving initiatives to a timely completion.To apply, submit your CV no later than Friday 17th January 2025.
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.
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