Main tasks:
- Assess the feasibility and risks associated with capital expenditure projects (CAPEX);
- Represent the customer's expectations and use your expertise to define requirements (URS) and design solutions;
- Manage suppliers through to completion of the FAT, SAT and equipment commissioning stages;
- Support the qualification of equipment in accordance with internal SOPs and ICH guidelines;
- Organise, where appropriate, the technical transfer of processes, including:
- Drawing up the transfer strategy and preparing or reviewing test protocols;
- Coordination of support departments (RA, QC, QA, Qualification/Validation, Development, IT, Supply Chain, HSE, Metrology, Purchasing, Facilities, Finance, Utilities, etc.);
- Preparing and programming equipment (manufacturing recipes);
- Managing experimental tests and checking that equipment is operating correctly;
- Passing on the technical know-how acquired during commissioning and qualification ;
- Support for the drafting of production documentation (SOPs, manufacturing instructions) ;
- Participation in training, validation protocols and reports ;
- Formalised sharing of knowledge on internal platforms (House of Knowledge type) ;
- Support customer teams during pre-approval inspections of new equipment or processes;
- Identify, propose and implement technical solutions to increase production capacity, reduce costs (COGS), improve efficiency and enhance quality compliance;
- Overseeing the strict application of health and safety rules and contributing to the continuous improvement of practices;
- Being in the front line for the handling of technical problems, investigations and deviations related to delivered equipment;
- Applying best engineering practices in terms of cost estimation, schedule management, levels of definition (LOD), project management, commissioning, etc.
