Project Engineer, WFI & GMP Utilities (Madrid)

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

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,