Project Engineer – Process Equipment Integration

About the role

PanTera is looking for a Project Engineer to lead the design, procurement, installation, testing and qualification of both GMP and non‑GMP equipment. You will work closely with suppliers and multidisciplinary teams to ensure reliable operation of hot cells, radiochemical separation systems, glove boxes, fumehoods, utilities and supporting process systems throughout their lifecycle.

Key responsibilities

• Support design, procurement, installation, commissioning and lifecycle management of GMP and non‑GMP process equipment.
• Define, validate and manage functional, mechanical and quality requirements, maintaining a traceability matrix.
• Collaborate with equipment suppliers from design through qualification and issue resolution.
• Prepare and review engineering and qualification documentation (URS, DQ, FAT, SAT, IQ, OQ, PQ) ensuring cGMP compliance.
• Review supplier documentation including P&IDs, mechanical drawings and electrical schematics.
• Participate in risk assessments (HAZOP, FMEA), maintain the risk register and track mitigation actions.
• Coordinate integration of equipment with utilities, automation, IT/OT and facility systems.
• Ensure complete, accurate technical documentation for design reviews, validation and long‑term operation.
• Act as backup for the Downstream Project Manager when required.

Required profile

• Master’s degree in Engineering (Electromechanics, Mechanical, Industrial) or equivalent experience.
• 2–3 years of experience with process equipment, project engineering or equipment integration in regulated or high‑technology environments.
• Experience with equipment design, procurement, installation, commissioning and qualification.
• Familiarity with GMP, nuclear or pharmaceutical standards is a strong asset.
• Knowledge of risk assessment methods (FMEA, HAZOP) and international standards (ISO, ASME, EHS, GMP) is an asset.

Required skills

• Equipment design, procurement, installation, commissioning, qualification
• GMP and cGMP compliance
• ISO, ASME standards
• Risk assessment methods (FMEA, HAZOP)
• Preparation of URS, DQ, FAT, SAT, IQ, OQ, PQ documentation
• Review of P&IDs, mechanical drawings, electrical schematics
• Integration with utilities, automation, IT/OT infrastructure