Commissioning And Qualification Lead
16 hours ago
Senior Commissioning Manager
We are seeking a skilled Commissioning and Qualification (C&Q) professional to lead our Process Engineering team at CSL Behring in Melbourne. This critical role ensures the successful commissioning and qualification of new and modified equipment, facilities, and utilities within our pharmaceutical manufacturing environment.
You will work closely with various stakeholders, including Manufacturing, Project Delivery, Quality, and Regulatory Affairs, as well as global and local counterparts across the Process Engineering organisation.
Responsibilities:
Develop comprehensive strategies for implementing complex systems and process technology, including automated processing equipment, facilities, and utilities.
Build, facilitate, and maintain execution programs based on qualification strategies for successful engineering project implementation and continuous improvement initiatives.
Review and implement best practices and standardized methodologies to enhance efficiency and effectiveness across engineering projects and continuous improvement initiatives.
Evaluate existing commissioning and qualification processes and identify opportunities for improvement.
Establish partnerships and collaborations with internal and external stakeholders to stay up-to-date with emerging trends, technologies, and best practices in commissioning and qualification.
Collaborate with the Process Engineering organisation to prioritise work, identify high-value improvements, and facilitate scoping and execution of implementation within internal PE functions and key partner functions.
Assist in departmental planning, performance, and process optimisation by identifying goals, objectives, and key performance indicators aligned with organisational priorities.
Implement and maintain performance metrics and monitoring mechanisms to track commissioning and qualification progress, completion status, and effectiveness.
Ensure compliance with safety and regulatory requirements during all phases of project delivery and C&Q activities.
Qualifications:
A degree in Engineering or Life Sciences, or equivalent.
At least 5 years' experience in Commissioning and Qualification within pharmaceutical manufacturing or a highly regulated industry.
Ideal experience in project, production, or process engineering within pharmaceutical manufacturing or a highly regulated manufacturing industry.
Knowledge of cGMPs, manufacturing operations in FDA-regulated facilities, 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 quickly and lead problem-solving initiatives to timely completion.
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