Engineering lead coordinator

Job title:

Company:

Jefferson Wells

Job description

Contracting – Brabant Wallon

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 SOPs and ICH guidance
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)
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, commissioning, …

Minimum 5 years of project management experience preferred.
Experience in regulated technical fields is a must.
Ability to identify and solve problems effectively.
Expertise in automation, packaging, medical devices, and GMPs. Approximately 60% expertise in each area: packaging, automation, and project management.
Good communication skills, capable of leading a meeting and autonomous.
English and French are mandatory.

Jefferson Wells offers you a permanent contract as consultant with an attractive salary package and will give you access to trainings in technical matters and soft skills. We will be your career partner for each step along the way. You’re interested in this job? We kindly invite you to apply or send me your CV,