KEY RESPONSIBILITIES:
- Manage the engineering equipment design – provide design and coordination support between the site and the package vendors.
- During the project phase, be responsible for equipment tracking and managing the schedule from design through to system release to operations.
- Ensure all equipment and processes are safe, effective and in compliance with industry standards and regulatory expectations.
- Authorship, review and approval of testing protocols and reports.
- Act as steward for all company and site engineering policies and procedures.
- Responsible for project delivery, vendor enquires 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 initiation and completion of deviations, CAPAs, and change controls for process systems including investigations relating to equipment or process performance.
- Ensure that new process systems are included in the plant maintenance and calibration program.
- Project management of process system upgrades and modifications.
- Perform all duties in accordance with SOPs and controlled documents.
- Will be flexible to take on additional tasks and responsibilities.
- Will act as a role model for the Engineering function and also the wider organisation in adherence to the corporate core values and culture.
REQUIREMENTS:
- A minimum of 3 – 5 years’ experience 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 (brown field or green field).
- Experienced 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 operating in a fully automated Delta V facility.
- Experience of equipment vendor package ownership and system design coordination
