Project Engineer - Fill&Finish (m/w/d)

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

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Facts about the job

Contract type
Coopers Group AG