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Project Engineer (Fill & Finish)
- Contract
- Project Engineering
- Switzerland
This vacancy has now expired. Please see similar roles below...
Proclinical are seeking a dedicated individual to be part of an innovative company that values inclusion, growth, and impact. Our dynamic work environment offers brilliant opportunities for advancement. We're seeking talented and driven individuals who share our passion for making a difference within the Life Science industry.
Key responsibilities
- Project Engineer Fill & Finish must supply engineering expertise to the project of the new plant extension at the clients 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 absent
- 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 the clients 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.
Contact me using the below:
S.Hubert@Proclinical.com
DL: +44 203 949 8594
CH: +41 61 508 7073
Mob: +44 7592 053 700
Apply now:
If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.
Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.
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