Project Engineer

PanTera is seeking a project engineer to oversee the design, procurement, installation, testing and qualification. The scope includes both GMP and non-GMP equipment such as hot cells, radiochemical separation systems, glove boxes, fumehoods, utilities and supporting process systems. You will work closely with suppliers and multidisciplinary teams to ensure the successful integration, qualification and reliable operation of process equipment throughout its lifecycle.

Responsibilities

• Support the design, procurement, installation, commissioning and lifecycle management of GMP and non-GMP process equipment, ensuring compliance with user requirements, safety standards and applicable regulations (ISO, ASME, GMP, etc.).
• Define, validate and manage functional, mechanical and quality requirements in collaboration with subject matter experts and Quality, maintaining the requirements traceability matrix throughout the project lifecycle.
• Collaborate with equipment suppliers throughout design, manufacturing, procurement, installation, testing, qualification and technical issue resolution.
• Prepare, review and execute engineering and qualification documentation, including URS, DQ, FAT, SAT, IQ, OQ and PQ, ensuring compliance with cGMP and project requirements.
• Review supplier documentation, including P&IDs, mechanical drawings, manufacturing drawings, electrical schematics, functional design specifications and other technical documentation.
• Participate in equipment risk assessments (HAZOP, FMEA, etc.), maintain the risk register, and ensure mitigation actions are implemented and tracked.
• Coordinate the integration of process equipment with utilities, automation, IT/OT infrastructure and facility systems, defining and managing interfaces between different process systems.
• Ensure complete, accurate and compliant technical documentation to support design reviews, equipment qualification, validation activities and long-term operation.
• Collaborate closely with QA, Validation, HSE, Automation, IT/OT, Maintenance, Operations and Facility engineering.
• Act as a backup for the Downstream Project Manager to ensure project continuity when required.

Profile

• Master’s degree in Engineering (Electromechanics, Mechanical Engineering, Industrial Engineering) or equivalent experience in high-technology industrial environments.
• Minimally 2–3 years of experience in process equipment, project engineering or equipment integration in industrial, nuclear, (radio)pharmaceutical, biotech, chemical or other regulated or high-technology environments.
• Experience with equipment design, procurement, installation, commissioning and qualification.
• GMP, nuclear or pharmaceutical experience is a strong asset.
• Knowledge risk assessment methods (e.g. FMEA, HAZOP or equivalent) is an asset.
• Understanding of international standards such as ISO, ASME, EHS and/or GMP principles is an asset.
• Strong technical expertise for critical review and challenge equipment design, procurement and integration of process equipments.
• Good understanding of system interfaces (utilities, automation, IT/OT) is an asset.
• Strong communication skills to interact with suppliers and multidisciplinary teams.
• Highly structured and organized mindset, capable of managing multiple technical interfaces and documentation streams in a complex project environment.
• Excellent written and verbal communication skills in English; Dutch and/or Italian is a plus.

You are also

• Eager to learn new fields and continuously update your knowledge
• Creative with your approach to work and thrive on bringing positive energy to your work
• A very committed person ready to work constructively and collaboratively with the team
• Organized and structured
• Capable of working autonomously and driving decisions
• A flexible person, willing to spend time on site (Mol in Antwerp province) and willing to travel occasionally
• Passionate and willing to contribute to a meaningful mission