For our customer located in Neuchatel/Switzerland we are currently looking for a: Project engineer Fill & Finish (m/f/d)
Tasks & Responsibilities
Project Engineer Fill & Finish must supply engineering expertise to the project of the new plant extension at the Neuchâtel 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.
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
- Applies the engineering best practices and guidelines to define the Detail Engineering
- Ensures implementation of divisional and corporate procedures and internal standards
- Follows training and keep them done in due time
- Acts as the Project engineer of another EWP when his counterpart is abse
Deliverables
- 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 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
- Definition of appropriate safety measures to prevent all risks of injury during the project
- Organization and coordination of working sessions with internal and external project teams as needed
- Other project deliverables may be added during the mission.
- Keep his/her Training up to date to be allowed to perform all the other activities mentioned in this list.
Did we catch your interest?
The SimplyVision-Team is looking forward to receive your application (Word file is highly appreciated).
Kindly be informed that our customer is located in Switzerland. Therefore only applications from candidates within the EU or candidates holding Swiss work permission are required.