The Manufacturing Engineer (Projects) is required to act as the Engineering Team's representative for ongoing projects. The manufacturing engineer (projects) will be responsible for overseeing projects ranging in nature from New Product Introduction, to improving machine capabilities and implementing continuous improvement projects. The right candidate will also ensure the projects comply with the relevant regulatory requirements as well as company specifications and requirements. This role will include design, scope definition, change control and project management.
- Responsible for Manufacturing Engineering Projects, liaising with vendors and troubleshooting of process systems where required.
- Participate on capital project teams through all phases of projects; these phases will include conceptual design, detailed design, equipment procurement, construction, installation, start up, commissioning, validation, and qualification.
- Responsible for initiation and completion of deviations, CAPAs, and change controls for process systems including investigations relating to equipment malfunctions.
- Oversee process system upgrades
- BEng in Chemical or Mechanical Engineering
- 3-6 years relevant experience in a cGMP commercial manufacturing environment (preferably Biopharma)
- Experience in project management of small scale projects in a cGMP commercial manufacturing environment
- Experience in troubleshooting and providing technical support for cGMP manufacturing operations and equipment in an aseptic processing environment
- Knowledge of and experience with GMP manufacturing systems (i.e. filling machines (Isolator and RABs technologies), ultrafiltration systems, autoclaves, parts washers, etc.)
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