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Project engineer Fill & Finish

Project engineer Fill & Finish

LocationGlattpark-Opfikon,, Switzerland
Business SectorBiotechnology
Contact email
Job ref23148
Publishedabout 1 month ago
Project Engineer Fill & Finish

Looking for a talented Plant Engineer with a Fill & Finish focus to join a thriving Biotech in Neuchâtel!

Description:

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

- Organizes, follows up and reviews project activities to the assigned internal and external parties, EpCM, suppliers, manufacturers, etc.

- 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

- Scheduling

- Supports maintenance and calibration in delivering their project activities

- Applies the engineering best practices and guidelines to define the Detail Engineering

- Acts as the Project engineer of another EWP 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 Takeda 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.)
- Update pre-HAZOP and HAZOP and define appropriate safety measures to prevent all risks of injury during the project

Presence on site is required for following SAT activities.