Site Engineer / Biomedical Engineer

Overview

This role involves relocation to Seychelles to support engineering operations at a medical facility. The engineer will manage installation, maintenance, validation, and project oversight of laboratory and cleanroom equipment, ensuring compliance with regulatory standards.

Key Responsibilities

• Oversee installation and commissioning of laboratory instruments and manufacturing systems, ensuring adherence to manufacturer specifications and user needs.
• Develop and execute preventive maintenance plans; conduct inspections, functional tests, troubleshoot equipment issues, and coordinate repairs in collaboration with external vendors.
• Assist in equipment qualification and validation processes including Installation, Operational, and Performance Qualification phases.
• Monitor and maintain cleanroom systems such as HVAC, HEPA filters, pressure, temperature, and humidity controls, gas, vacuum, and water purification systems; contribute to certification activities.
• Ensure dependable operation of utility systems including electrical, UPS, emergency power, fire safety, and medical gas infrastructure.
• Manage engineering projects from planning through execution, including drafting technical specs, vendor evaluation, timeline and budget management, and supervising contractors.
• Maintain compliance with GMP, GTP, ISO, and national regulations; prepare for audits and inspections by maintaining comprehensive engineering documentation and supporting corrective/preventive measures.
• Document and file maintenance, calibration, qualification, validation, service reports, SOPs, and logs in accordance with GMP and document control standards.

Qualifications and Experience

• Bachelor's degree in Biomedical Engineering, Civil Engineering, Project Engineering or related discipline.
• 3 to 5 years of experience in cGMP-regulated environments, preferably within cellular therapy or biotechnology laboratories.
• Hands-on exposure to cleanroom facilities, laboratory equipment management, HVAC systems, building management systems, and project management.
• Preferred certifications: PMP, Network Systems, AutoCAD, and GMP compliance.