Position: Process/Project Engineer - Purification System Owner Group
Duration - 18 months
Responsible for providing engineering support to a large-scale biopharmaceutical project during all phases from design through to qualification.
This role focuses on supporting the technical aspects of design, procurement, installation, commissioning and qualification of the bio process equipment associated with drug substance purification unit operations. The engineer will be responsible for providing routine technical support and oversight throughout the project lifecycle.
* Review and approve design documents including URSs, General Arrangement drawings and P&IDs.
* Support HAZOPs and design review meetings.
* Provide technical input and oversight to all aspects of engineering design.
* Review testing protocols, reports and applicable manufacturing SOPs.
* Ensure all equipment installed is safe, effective and in compliance with industry standards and as per the design intent.
* Support equipment commissioning and qualification.
* Provide routine equipment technical support and troubleshooting.
* Provide technical training on process and equipment as required by Operations.
Qualifications & Experience:
* Minimum qualification of a Primary Degree in Engineering, Science or equivalent with emphasis in biochemical engineering.
* Demonstrated ability to provide technical solutions for complex problems through equipment/process knowledge.
* Excellent communication and interpersonal skills and an ability to work independently
* Aptitude in leading and managing project work/teams.
* A collaborative approach to problem solving
* Experience and understanding of process, unit operations, and equipment associated with commercial biotechnology purification processes:
* Filtration (Terminal and TFF)
* Single use assemblies
* Aseptic techniques
* CIP & SIP