Method Engineer Biosimilar

Job Scope:

The Method Engineer is responsible for designing, improving, and optimizing manufacturing processes to enhance efficiency, quality, and productivity. He develop standard operating procedures, analyze workflows, and implement continuous improvement initiatives to ensure operational excellence.

Job Requirements:

• Education : Engineer's or master’s degree in industrial engineering, Process Engineering, Mechanical Engineering, Automation, or a related field.

• Experience : 2 to 4 years of professional experience in a similar position, ideally in the pharmaceutical industry.

• Professional Knowledge:

-Good knowledge of GMP requirements and ISO 9001 Standards.

-Proficiency in Office Software.

-Good knowledge of CMMS (Computerized Maintenance Management System) software.

-Ability to write technical and documentation documents.

-Strong organizational skills and ability to work effectively in a team.

-Results-oriented and committed to continuous improvement.

-Good written and oral communication skills in French and English.

Duties and Responsibilities:

-Define, write, and update the Engineering Department's documentation system, including Standard Operating Procedures (SOPs) and technical documents in accordance with GMP requirements and internal procedures.

- Participate in the standardization of practices and the improvement of technical documentation.

- Develop, follow-up and analyse the Engineering Department's Key Performance Indicators (KPIs).

- Participate in continuous improvement and operational excellence projects.

- Contribute to technical investigations and root cause analysis, as well as the implementation of Corrective and Preventive Actions (CAPA) and all QMS related documents.

- Ensure compliance with HSE rules, industrial safety standards, and applicable pharmaceutical regulations.

- Collaborate with various departments to establish and monitor the engineering activity schedule.

- Ensure the monitoring, coordination, and reporting of preventive and corrective maintenance activities.

- Participate in internal audits, regulatory inspections, and periodic department meetings.

- Ensure the follow-up of the Engineering staff training plan and training files in accordance with the Training / Compliance department.