Project Engineer Fill & Finish

CONTEXT & RESPONSIBILITIES:

Project Engineer Fill & Finish must supply engineering expertise to the project of the new plant extension at the Company site, namely NFA project, from project planning and execution till reporting phases.

Additionally, the Project Engineer shall support the delivery of project in interaction with the internal project team, with the selected EpCM, contractors and equipment manufacturers.

Project Engineer Fill & Finish, Neuchatel, Fulltime

Reporting to the Engineering Work Package (EWP) Lead, the Project Engineer Fill & Finish:

• Is primary contact for the project regarding technical aspects.
• Gives input for the project treated by the Project Engineering Subteam in order to define the Detail Eng., the project schedule incl. the required downtime to execute the project NFA.
• Organizes, follows up and reviews project activities to the assigned internal and external parties, EpCM, suppliers, manufacturers, etc.
• Is managing clear communication between stakeholders to achieve project objectives and project schedule.
• Drives project risk analysis to support to the Management to take decisions.
• Does identify financial aspects for the changes of scope if any.
• Is proposing corrective actions or improvements based on the lessons learnt of previous projects.
• Defines qualification documents in collaboration with quality engineers, Validation, QA-Val and QA.
• Does identify required project documentation with the team, using the QRM-methodology and the ASTM 2500 approach.
• Ensures permanent update of project documentation and schedule in close collaboration with the service groups.
• Supports maintenance and calibration in delivering their project activities.
• Ensures implementation of divisional and corporate procedures and internal standards.
• Acts as the Project engineer of anotherEWP when his counterpart is absent.

Deliverables concerned:

• NFA as a Project Engineer Fill & Finish as well as the tasks owner for elements of the general program. Support the Basic and Detail design, FAT, installation, commissioning/SAT and qualification (PQ) of the assigned EWP.
• Project preparation as the technical engineering SME and Company representative for NFA execution phases as well as the anticipated project activities/implementations during the current operation.
• Support to the EWP Lead and to the Project Engineering Lead in writing of URS, FDS, protocols for the new facility extension composed by Aseptic Filling equipment, Freeze Dryers (Lyophilisers), Isolator technology (incl VHP decontamination), CIP systems, sterile filtration, Formulation & Buffer Preparation, part washers, autoclave, stopper processor and material preparation.
• Ensure compatibility and consistency with existing organization (site, divisional and corporate) procedures and industry standards (cGMP, GEP, SUVA/ASIT etc.).
• Define appropriate safety measures and implement them to prevent all risks of injury during the project.
• Update pre-HAZOP and HAZOP.
• Organization and coordination of working sessions with internal and external project teams as needed.

Apply:

Please quote job reference 100551 in all correspondence.