Your role

A full-time fixed-term position for 18 months has become available for a Senior Computer System Validation (CSV) Specialist. Based at Broadmeadows, you will ensure all computerised systems used to support Good Manufacturing Practice (GMP) operations are validated and controlled for an innovative Automation project.

Your Responsibilities

Reporting to the CSV Lead, you will:

• Work with local and global CSV teams to build agreement of validation expectations
• Work with project execution systems team to ensure the oversight of CSV activities associated with the project
• Provide support of change management processes in collaboration with Quality
• Support the validation strategy/validation master plan with the Quality organisation
• Oversee the preparation, delivery, and execution of CSV owned validation protocols
• Manage the System Development Lifecycle and maintaining the validated the state of computerised systems
• Oversee Data Integrity Assessment execution and help with periodic review assessments

Your Experience

• 5+ years' experience with CSV methodologies in pharmaceutical and biotechnology industries
• Experience with CSV regulations like Annex 11 and 21 CFR Part 11
• Experience in writing and reviewing CSV qualification documents (IQ, OQ, PQ)
• Experience in CSV inspection readiness preparations and supporting regulatory agency inspections
• Understanding of industry guidelines related to computerised systems like GAMP5
• Knowledge of Software Development Lifecycle (SDLC) model and a risk-based approach to validation of computerised systems
• Exposure to technologies, including automated data collection, historian applications (OSI PI), SCADA, automated decision control (Batch), workflow (MES), database applications, and interfaces to ERP and LIMS would be regarded
• Experience with electronic document management systems and paperless validation software will be regarded.
• Bachelor's in Engineering, Computer Sciences or similar field

Apply now to support CSL Behring during our next phase of growth.

To apply submit your CV no later than Monday 20th May 2024

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