Project Engineer / Ingenieur Fill & Finish | Neuchatel, CH

Job description:

On behalf of our client based in the pharmaceutical industry, we are looking for a Project Engineer who shall support the delivery of the project in interaction with the internal project team and the equipment manufacturers.

Please note that this is a 2-month contract from ASAP to 28.03.2025.

The successful Project Engineer Fill & Finish will manage responsibilities which include:

• Being the primary point of contact for the project regarding technical aspects.
• Organizing follow-ups and reviewing project activities with the assigned internal and external parties and manufacturers.
• Managing clear communication between stakeholders to achieve project objectives and schedule.
• Driving project risk analysis to support Management in decision-making.
• Proposing corrective actions or improvements based on lessons learned from previous projects.
• Defining qualification documents in collaboration with quality engineers, Validation, QA-Val, and QA.
• Ensuring permanent updates of project documentation and schedule in close collaboration with the service groups and supporting maintenance and calibration in delivering their project activities.
• Writing protocols/reports for the new facility extension composed of Aseptic Filling equipment, Freeze Dryers (Lyophilisers), Isolator technology (including VHP decontamination), CIP systems, sterile filtration, Formulation & Buffer Preparation, part washers, autoclave, stopper processor, and material preparation.

Requirements:

• Previous experience as a project engineer, specifically in the pharmaceutical, biotechnology, or life sciences industries.
• Experience conducting risk analysis (e.g., HAZOP analysis).
• Experience with fill & finish processes , including aseptic filling equipment, freeze dryers (lyophilizers) , isolators , CIP systems , and related pharmaceutical manufacturing technologies.
• Strong understanding of cGMP (current Good Manufacturing Practices) , GEP (Good Engineering Practices) , QRM (Quality Risk Management) , and ASTM 2500 .
• Experience in managing project documentation (e.g., protocols, reports) and the qualification of manufacturing equipment (including SAT and PQ ).

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