Project Engineer

Project Engineer Fill&Finish

Are you experienced in comissioning of filling lines within pharmaceutical industry? Here is a unique opportunity to support our client with implementing a new filling line and leverage your know-how in that field.

Duration: end of 2024

Main tasks:

primary contact for the project regarding technical aspects
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
follows up and reviews project activities to the assigned internal and external parties, EpCM, suppliers, manufacturers, etc.
managing clear communication between stakeholders to achieve project objectives and project schedule
project risk analysis to support to the Management to take decisions
identify financial aspects for the changes of scope if any
proposing corrective actions or improvements based on the lessons learnt of previous projects
qualification documents in collaboration with quality engineers, Validation, QA-Val and QA
identify required project documentation with the team, using the QRM-methodology and the ASTM 2500 approach
permanent update of project documentation and schedule in close collaboration with the service groups
maintenance and calibration in delivering their project activities

Deliverables concerned:

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
preparation as the technical engineering SME and Takeda representative for NFA execution phases as well as the anticipated project activities/implementations during the current operation
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.
compatibility and consistency with existing organization (site, divisional and corporate) procedures and industry standards (cGMP, GEP, SUVA/ASIT etc.)
appropriate safety measures and implement them to prevent all risks of injury during the project
pre-HAZOP and HAZOP

Das klingt nach einer spannenden Position?
Dann freuen wir uns über vollständige Bewerbungsunterlagen per Onlineformular.

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