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 c GMP (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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