Since 1998,PQE Grouphas been at the forefront of these industries, with 40 subsidiaries and more than 2,000 employees across Europe, Asia and the Americas. Working for a consultancy such as PQE Group will give you the opportunity to contribute to projects for some of the most important pharmaceutical companies at both national and international level.We are looking for an experiencedProject Engineerto support an engineering project focused onWater for Injection (WFI) generation and clean and black utilitieswithin a GMP-regulated pharmaceutical manufacturing environment.The role will support the Project Manager throughout the execution of the project, including the management and coordination of external contractors and daily project activities. A key objective will be to ensure the implementation of the project whilemaintaining GMP compliance and avoiding disruption to ongoing production activities .The first assignment will be based inTres Cantos (Madrid)for an initial period of approximately one year. Upon completion of the project, the successful candidate will have the opportunity to be assigned to other projects based at ourMadrid office .Key ResponsibilitiesSupport the Project Manager in the planning, coordination and execution of the WFI generation and utilities project.Support the management and coordination of external contractors and follow up their daily activities.Coordinate activities related toclean utilities and black utilities, ensuring alignment with project requirements.Ensure project activities are performed in compliance withGMP, quality and EHS requirements .Support the implementation and maintenance ofchange controls, deviations and CAPAprocesses.Coordinate with QA/Compliance, EHS, Engineering and Manufacturing teams to ensure effective project execution.Support the preparation and review of regulatory and technical documentation.Support the development and review of procedures andSOPs,



ensuring appropriate document control.Monitor project activities, deliverables, milestones and potential risks, supporting the Project Manager in the implementation of corrective actions.Ensure project execution is coordinated with ongoing manufacturing activities, minimizing impact on current production.Support qualification and requalification activities associated with the projectParticipate in project meetings, technical reviews and coordination activities with internal and external stakeholders.RequirementsUniversity degree inEngineering, Chemical Engineering, Mechanical Engineering, Industrial Engineeringor a related discipline.Previous experience inproject engineering or project managementwithin pharmaceutical, biotechnology, life sciences or other GMP-regulated environments.Experience withWFI, clean utilities and/or black utilitiesis highly desirable.Experience supporting engineering projects involving contractors and multidisciplinary teams.Good understanding ofGMP requirements, change control, deviations, CAPA and qualification activities .Experience with HVAC systems, GxP systems, temperature monitoring systems or pharmaceutical utilities will be considered a strong asset.Experience with project documentation, SOPs, technical procedures and document control.Strong organizational, coordination and communication skills.Ability to work effectively withQA/Compliance, EHS, Engineering and Manufacturingteams.Ability to work in an operational manufacturing environment while ensuring business continuity and minimizing disruption to production.Fluent/advanced English and Spanish are required.Salary starting from €40,000 gross per year.Working at PQE GroupAs a member of the PQE team, you will join a multicultural and stimulating company that values collaboration and innovation. PQE Group offers you the opportunity to work on international projects, develop your skills and interact with colleagues from all over the world.If you are looking for a rewarding and exciting career,PQE Group is the perfect place for you .#J-18808-Ljbffr

📌 Project Engineer – Wfi & Utilities (Madrid)
🏢 Pqe Group
📍 Madrid