engineering lead coordinator - 13722.

• To evaluate the feasibility and risk associated with Capital Investment (CAPEX) projects

• To relay customer consideration and take benefit of his expertise in the definition of requirement (URS) and the solution design

• To ensure the management of the supplier until the FAT, SAT and commissioning

• To support the qualification according to client's SOPs and ICH guidances

• When applicable to organize the process technical transfer. This includes : To elaborate the technical transfer strategy and to prepare/review of the test protocols. His input should be based on his technical background and the knowledge of the equipment to define a plan technically feasible and acceptable on GMP aspect. To coordinate support departments (RA, QC, QA, Qualification/Validation, Development, Technical Services, Industrial IT, Supply Chain, HSE, Metrology, Sourcing, Facility, Finance, Utilities…) for projects implementation. To prepare the equipment and to program the recipes on manufacturing equipment. To ensure that the equipment runs properly and if needed to connect with supporting services (maintenance, IT and external supplier/service providers)o He should lead the operations during an experimental run

• To deliver to the client the technological know-how capitalized during commissioning and qualification campaign. This includes supporting the preparation of manufacturing documentation (SOPs & manufacturing instructions), the training sessions and validation protocols and reports. When applicable sharing formalized knowledge on the House of Knowledge platform.

• To support the client department for pre-approval inspections of delivered new equipment and processes.

• To identify, propose and implement technical solutions to improve plant capacities, to reduce COGS, to increase efficiency and improve Quality compliance

• To supervise the strict application of Safety & Hygiene rules and foster development of improved practices.

• Front line in process problem solving, investigations and deviations related to delivered equipment.

• To apply engineering best practices in term of cost estimate, scheduling management, LOD, project workflow, commissionning, …

- Bachelor or master degree in engineering

- Knowhow in automation, packaging and medical devices technologies

- Senior experience on Project management methodology

- Prioritization skills and ability to successfully manage multiple tasks simultaneously.

- Team work : ability to work well in highly cross functional and inter-site team environment

- Communication skills : ability to express clearly and concisely within a team.

- To adjust communication style for the audience.

- To timely and effectively communicate on issues.

- Technical writing skills to support authorship of internal documentation.

- Knowledge sharing : ability to capture and to digest information from multiple sources and to build intelligible knowledge to be shared with project clients.

- Knowledge of GMPs