Project Engineer Aseptic Filling Equipment

Responsibilities

• As Project Engineer Aseptic Filling Equipment you are responsible for project engineering activities related to filling equipment (filling lines, isolators, e-beams, washers, tunnels and/or cappers)
• You provide technical input in the project team for own discipline
• You know how the installation or system function and know the internal requirements (operational/technical/compliance)
• You define and document the technical specs (Engineering Design Specification or technical spec, P&ID’s, electrical diagrams) and review with the relevant SME
• You follow the engineering standards and align with the lead engineer during design, construction and implementation
• You follow up the construction, implementation and functioning of the equipment to guarantee the installation is according to spec
• You guarantee good project management practices and tools (schedule, budget control, issues, decisions, reporting, stakeholder management, …) for own equipment/installation/scope
• You keep oversight of the contractor company that will build, install or test the equipment
• You transfer the equipment to operations, deliver all project documentation and close out of the project
• You follow start up results to guarantee that the project deliverables were achieved
• You assure correct documentation of construction and verification/validation on the engineering project folder
• You are responsible for defining and executing the engineering tests, verification and validation of own equipment
• You define the validation approach, create test protocols for engineering tests, create verification and validation documents, execute tests, coordinates SME and system owner approvals
• You solve and document deviations and actions (CAPA’s, risk assessments, cGMP review, new document versions)

Requirements

• Master in technical field
• Experience in executing engineering projects
• Experience in planning and project coordination (MS Project is a plus)
• Experience within pharmaceutical environment
• Good communication & documentation skills
• Pragmatic, pro-active, can take the lead
• Able to motivate
• Results focused
• Able to work independently but is also a team player
• Quality minded
• Safety minded
• Hands-on and good problem solving skills
• Show ownership