Method Engineer Biosimilar

About the role

The Method Engineer Biosimilar will design, improve and optimise manufacturing processes for biosimilar products. The role focuses on enhancing efficiency, quality and productivity while ensuring compliance with regulatory standards.

Key responsibilities

• Define, write and update SOPs and technical documents in line with GMP and internal procedures.
• Participate in standardisation of practices and improvement of technical documentation.
• Develop, monitor and analyse engineering KPIs.
• Support continuous‑improvement and operational‑excellence projects.
• Contribute to investigations, root‑cause analysis and implementation of CAPA.
• Ensure compliance with HSE rules, industrial safety and pharmaceutical regulations.
• Coordinate engineering activity schedules with other departments.
• Monitor, coordinate and report preventive and corrective maintenance activities.
• Participate in internal audits, regulatory inspections and departmental meetings.
• Support training plans and maintain training records for engineering staff.

Required profile

• Engineer’s or Master’s degree in Industrial, Process, Mechanical Engineering, Automation or related field.
• 2‑4 years of experience in a similar role, preferably in the pharmaceutical industry.
• Good written and oral communication skills in French and English.

Required skills

• Knowledge of GMP requirements.
• Familiarity with ISO 9001 standards.
• Proficiency with Office software.
• Experience using CMMS (Computerised Maintenance Management System) software.