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Computer Systems Validation Specialist
This role will be involved in the design and CSV activities for the upstream and downstream packages to enable start-up of the processing facility and for the ongoing CSV activities during sustaining operations. The CSV Engineer is responsible for ensuring that all manufacturing process, QC and Enterprise systems perform and operate as per their design. The CSV Engineer ensures that all systems, conform to relevant regulatory requirements as well as company specifications and standards.
Essential Duties and Responsibilities
• Support the process control system qualification – from design through to operational use.
• During the project phase, be responsible for control system tracking and managing the schedule from design through to system release to operations.
• Ensure all control elements are safe, effective and qualified in compliance with industry standards and regulatory expectations.
• Authorship, review, approval and execution of testing protocols, reports, policies and masterplans.
• Act as steward for all company and site CSV and revalidation policies and procedures.
• Oversee the compliant execution and reporting of all CSV activities for process and support systems.
• Responsible for project delivery, vendor enquires and the troubleshooting and monitoring of process control systems.
• Participate on project teams through all phases of projects – conceptual and detailed design, equipment procurement, construction, installation, start up, commissioning and qualification, and system release
• Responsible for initiation and completion of deviations, CAPAs, and change controls for process control systems including investigations relating to equipment or process performance.
• Support all hardware and software updates and revisions.
• Support / lead the resolution of significant production related deviations and events.
• Ensure that new process systems are included in the plant maintenance and calibration program.
• Project management of process system upgrades and modifications.
• B.Eng or B.Sc in Chemical Engineering / Computer Science or other relevant qualification is desirable.
• Experience working in a Biologics or similar GMP environment as part of an engineering, technical services or automation / IT function.
• Experienced in the execution of commissioning and qualification of process control systems (e.g. Delta V), PLC and SCADA systems and Enterprise systems.
• Experience in troubleshooting and providing technical and engineering solutions for GMP manufacturing operations in a biologics processing environment.
• Experience operating in a fully automated Delta V facility.
• Experience in establishing the procedures, policies and masterplans that define a CSV and revalidation program.
• A postgraduate qualification in an automation or IT discipline would be advantageous.
• A qualification in project management would be advantageous.
• Technical / engineering knowledge of Upstream and / or Downstream biologics control systems would be advantageous.
• Knowledge and experience with facility start-up projects (brown field or green field) would be advantageous.