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. You will be responsible for ensuring that all manufacturing process, QC and Enterprise systems perform and operate as per their design.
- The CSV Engineer will 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 masterplan
- You will 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.
- You will support all hardware and software updates and revisions.
- You should have a degree in Science or Computer Science and experience working within a biopharma or pharmaceutical industry
- Technical knowledge of Upstream or Downstream biologics control systems would be advantageous
- 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.
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