Our client is a Global Pharmaceutical Manufacturer that focuses on Human Vaccine Discovery, Development, and Manufacturing and they are looking to hire an experienced CSV Engineer to join their expanding team.
The successful candidate will be involved in the design, construction, and qualifications for the upstream and downstream packages to enable the start-up of the processing facility and for the ongoing process engineering and validation activities during sustaining operations.
- Manage engineering equipment design- provide design and coordination support between the site and the package vendors during project phases.
- During the Project phase, be responsible for equipment tracking and managing the schedule through to system release to operations.
- Ensure all equipment and processes are safe, effective, and in compliance with industry standards and regulatory expectations.
- Responsible for project delivery, vendor inquiries, and the troubleshooting and monitoring of process 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 the initiation and completion of deviations. CAPAs and change controls for process systems including investigations relating to equipment or process performance.
- B.Eng. or B.Sc. in Chemical/Process Engineering or a relevant science discipline is required.
- Minimum of 3 Years Experiences working in a Biologics or similar GMP environment as part of an engineering, technical services or operations function.
- Knowledge and experience with facility start-up projects.
- Experience in the execution of commissioning and qualification of process equipment (e.g. bioreactors and process vessels, chromatography, ultrafiltration, autoclaves, parts washers)
- Experience in troubleshooting and providing technical and engineering solutions for GMP Manufacturing operations and equipment in a biologics processing environment.
- Experience of equipment vendor package ownership and system design coordination.
- Excellent Communication, interpersonal and presentation skills.
*FULL SPEC ON APPLICATION*
If you would like more information on this role you can contact Paul Dunican
(090) 641 702