SITE ENGINEER / BIOMEDICAL ENGINEER

Relocation to Seychelles.

-        Equipment Installation & Commissioning: Coordinate installation of laboratory equipment and manufacturing systems, verify equipment installation in accordance with manufacturer specifications and user requirements, support commissioning of new laboratory equipment's and cleanrooms.

-        Equipment Maintenance: Develop and implement preventive maintenance schedules, perform routine inspections and functional testing of laboratory equipment, troubleshoot equipment malfunctions and arrange repairs, coordinate with external service providers for specialized maintenance, maintain equipment uptime to support uninterrupted laboratory operations.

-        Equipment Qualification & Validation: Support Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ), assist in validation of laboratory equipment and computerized systems.

-        Cleanroom & Facility Systems: Monitor and maintain cleanroom engineering systems including HVAC systems, HEPA filtration, differential pressure monitoring, temperature and humidity control, compressed gases, vacuum systems, purified water systems (if applicable), and environmental monitoring equipment, support cleanroom certification activities.

-        Utility Systems: Ensure reliable operation of electrical systems, UPS systems, backup generators, emergency power systems, fire alarm and suppression systems, and medical gas systems.

-        Project Management: Plan and coordinate engineering projects from concept through completion, prepare technical specifications for equipment procurement, participate in vendor selection and technical evaluations, monitor project timelines, budgets, and deliverables, coordinate contractors and installation activities.

-        Quality & Regulatory Compliance: Ensure engineering activities comply with GMP, GTP, ISO standards, and applicable national regulations, participate in internal and external audits, support regulatory inspections by providing engineering documentation, implement corrective and preventive actions related to engineering findings.

-        Documentation: Prepare and maintain equipment files, maintenance records, calibration records, qualification reports, validation documentation, service reports, engineering SOPs, and preventive maintenance logs. ensure documentation complies with GMP and document control requirements.

Qualifications:

-        Bachelor's Degree in Biomedical Engineering, Civil Engineering, Project Engineering or related.

-        3-5 years of relevant experience in cGMP regulated, Cellular therapy or Biotechnology Laboratories.

-        Experience with cleanroom facilities, laboratory equipment, HVAC systems, BMS and Project management is highly desirable.

-        Additional certifications of PMP, Networking systems, AutoCAD and GMP preferred.