Project Engineer – WFI & Utilities

PQE Group; Madrid; On-site; EUR 36,000 - 44,000; Full time

Job summary

PQE Group seeks an experienced Project Engineer to support an engineering project focused on Water for Injection (WFI) generation and clean/black utilities within a GMP-regulated pharmaceutical environment. You will support the Project Manager and coordinate external contractors to ensure GMP compliance and minimize production disruption.

The initial assignment is based in Tres Cantos (Madrid) for about one year, with potential to join other Madrid projects and collaborate with QA/Compliance,

Qualifications

• University degree in Engineering or related discipline.
• Experience in project engineering/management within GMP environments.
• Experience with WFI, clean/black utilities is desirable.
• Experience coordinating contractors and multidisciplinary teams.
• Strong GMP, change control, deviations, CAPA and qualification understanding.
• HVAC, GxP, temperature monitoring assets are a plus.

Responsibilities

• Support the Project Manager in planning, coordinating and executing the WFI and utilities project.
• Coordinate external contractors and monitor their daily activities.
• Align activities with clean/black utilities requirements and project needs.
• Ensure GMP, quality and EHS requirements are followed in all tasks.
• Support change controls, deviations and CAPA processes.
• Collaborate with QA/Compliance, EHS, Engineering and Manufacturing teams.
• Assist with regulatory and technical documentation review.
• Develop and review procedures and SOPs with proper document control.
• Monitor milestones, risks and actions; support corrective actions as needed.
• Coordinate with manufacturing to minimize production disruption.
• Assist in qualification and requalification activities during the project.
• Participate in project meetings and technical reviews with stakeholders.

Skills

GMP knowledge

Contractor management

Project coordination

English & Spanish fluency

Education

Engineering

Chemical Engineering

Mechanical Engineering

Industrial Engineering

Job description

Since 1998, PQE Group has 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 experienced Project Engineer to support an engineering project focused on Water for Injection (WFI) generation and clean and black utilities within 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 while maintaining GMP compliance and avoiding disruption to ongoing production activities.

The first assignment will be based in Tres 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 our Madrid office.

Key Responsibilities

• Support 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 to clean utilities and black utilities, ensuring alignment with project requirements.
• Ensure project activities are performed in compliance with GMP, quality and EHS requirements.
• Support the implementation and maintenance of change controls, deviations and CAPA processes.
• 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 and SOPs, 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 project
• Participate in project meetings, technical reviews and coordination activities with internal and external stakeholders.

Requirements

• University degree in Engineering, Chemical Engineering, Mechanical Engineering, Industrial Engineering or a related discipline.
• Previous experience in project engineering or project management within pharmaceutical, biotechnology, life sciences or other GMP-regulated environments.
• Experience with WFI, clean utilities and/or black utilities is highly desirable.
• Experience supporting engineering projects involving contractors and multidisciplinary teams.
• Good understanding of GMP 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 with QA/Compliance, EHS, Engineering and Manufacturing teams.
• 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 Group

As 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.