Project engineer Fill - Neuchâtel, Schweiz - Randstad

Beschreibung

Jobdescription
For ourclient, an international company based in Neuchâtel, we are lookingfor a Project engineer Fill & Finish.

Project Engineer Fill & Finish must supply engineeringexpertise to the project of the new plant extension, namely NFAproject, from project planning and execution till reportingphases.

Additionally, the Project Engineershall support the delivery of project in interaction with theinternal project team, with the selected EpCM, contractors andequipment manufacturers.

GeneralInformation:

• Start date:ASAP
• Enddate: 30/09/2024
• Workplace:Neuchâtel
• Workload:100%
• Home office: Presence on site isrequired for following SAT activities

Tasks and responsibilities:

Reporting to the Engineering Work Package (EWP) Lead, theProject Engineer Fill & Finish:

• Is primarycontact for the project regarding technicalaspects
• Gives input for the project treated bythe Project Engineering Subteam in order to define the Detail Eng.,the project schedule incl. the required downtime to execute theproject NFA
• Organizes, follows up and reviewsproject activities to the assigned internal and external parties,EpCM, suppliers, manufacturers, etc.
• Ismanaging clear communication between stakeholders to achieveproject objectives and project schedule
• Drivesproject risk analysis to support to the Management to takedecisions
• Does identify financial aspects forthe changes of scope if any
• Is proposingcorrective actions or improvements based on the lessons learnt ofprevious projects
• Defines qualificationdocuments in collaboration with quality engineers, Validation,QA-Val and QA
• Does identify required projectdocumentation with the team, using the QRM-methodology and the ASTM2500 approach
• Ensures permanent update ofproject documentation and schedule in close collaboration with theservice groups
• Supports maintenance andcalibration in delivering their projectactivities
• Applies the engineering bestpractices and guidelines to define the DetailEngineering
• Ensures implementation ofdivisional and corporate procedures and internalstandards
• Follows training and keep them donein due time
• Acts as the Project engineer ofanother EWP when his counterpart isabsent
• Keeps his/her Training up to date to beallowed to perform all the other activities mentioned in thislist.

Deliverablesconcerned:

• NFA as a ProjectEngineer Fill & Finish as well as the tasks owner for elementsof the general program. Support the Basic and Detail design, FAT,installation, commissioning/SAT and qualification (PQ) of theassigned EWP
• Project preparation as thetechnical engineering SME and the company representative for NFAexecution phases as well as the anticipated projectactivities/implementations during the currentoperation
• Support to the EWP Lead and to theProject Engineering Lead in writing of URS, FDS, protocols for thenew facility extension composed by Aseptic Filling equipment,Freeze Dryers (Lyophilisers), Isolator technology (incl VHPdecontamination), CIP systems, sterile filtration, Formulation& Buffer Preparation, part washers, autoclave, stopperprocessor and material preparation.
• Ensurecompatibility and consistency with existing organization (site,divisional and corporate) procedures and industry standards (cGMP,GEP, SUVA/ASIT etc.)
• Define appropriate safetymeasures and implement them to prevent all risks of injury duringthe project
• Update pre-HAZOP andHAZOP
• Definition of appropriate safety measuresto prevent all risks of injury during theproject
• Organization and coordination ofworking sessions with internal and external project teams asneeded
• Other project deliverables may be addedduring the mission.