Project Engineer: GMP Equipment Design & Qualification

PANTERA; Mol; Sur place; EUR 55 000 - 75 000; Plein temps

Résumé du poste

PanTera is seeking a project engineer to oversee the design, procurement, installation, testing and qualification of GMP and non-GMP equipment. The role involves coordinating with suppliers and multidisciplinary teams to ensure successful integration and ongoing operation of process equipment.

The candidate should have a Master’s degree in Engineering and 2–3 years of experience in regulated environments, with strong English communication.

Qualifications

• Master’s degree in Engineering or equivalent experience in high-technology industrial environments.
• Minimally 2–3 years of experience in process equipment, project engineering or equipment integration in regulated/high-technology environments.
• Experience with equipment design, procurement, installation, commissioning and qualification.
• GMP, nuclear or pharmaceutical experience is a strong asset.
• Knowledge of risk assessment methods (e.g. FMEA, HAZOP) is an asset.
• Understanding of ISO, ASME, EHS and GMP principles is an asset.
• Strong technical expertise for reviewing and integrating process equipment.
• Good understanding of system interfaces (utilities, automation, IT/OT).
• Excellent written and verbal communication in English; Dutch and/or Italian is a plus.

Responsabilités

• Support the design, procurement, installation, commissioning and lifecycle management of GMP and non-GMP process equipment.
• Define, validate and manage functional, mechanical and quality requirements with SMEs and Quality.
• Collaborate with equipment suppliers through design, manufacturing, procurement, installation, testing, and issue resolution.
• Prepare, review and execute URS, DQ, FAT, SAT, IQ, OQ and PQ documentation.
• Review supplier documentation (P&IDs, drawings, electrical schematics, etc.).
• Participate in risk assessments (HAZOP, FMEA) and maintain risk register.
• Coordinate integration of process equipment with utilities, automation, IT/OT, and facility systems.
• Ensure compliant technical documentation for design reviews, qualification, validation and operation.
• Collaborate with QA, Validation, HSE, Automation, IT/OT, Maintenance, Operations and Facility engineering.
• Act as a backup for Downstream Project Manager to ensure continuity.

Connaissances

Project engineering

Communication skills

Autonomy

Formation

Master's degree in Engineering

Description du poste

PanTera is seeking a project engineer to oversee the design, procurement, installation, testing and qualification of GMP and non-GMP equipment. The role involves coordinating with suppliers and multidisciplinary teams to ensure successful integration and ongoing operation of process equipment.

The candidate should have a Master’s degree in Engineering and 2–3 years of experience in regulated environments, with strong English communication.