Senior Facility Engineer

Job Title / Job Code:

Senior Facility Engineer

Function: Facility

Location: Singapore

Summary

The Senior Facility Engineer is responsible for planning, coordinating, commissioning, qualifying, operating, and maintaining the facility and utilities equipment, EHS and cleanroom infrastructure supporting Balance Medical Singapore's Class III implantable medical device manufacturing facility.

The role will lead engineering activities during facility construction, cleanroom commissioning, facility and utility equipment installation, qualification(DQ/IQ/OQ/PQ), preventive maintenance, calibration, contractor management, and facility expansion while ensuring compliance with ISO 13485, FDA QMSR, EU MDR, and applicable Singapore regulatory requirements.

Responsibilities

· Design & Authority Approval: Own revised facility layout for segregated chemical storage, secondary containment, exhaust and scrubber sizing. Prepare and lead submissions for NEA Hazardous Substances Permit, SCDF Fire Safety / Flammable Materials store license, BCA /JTC approvals for roof loading and exhaust louvres, PUB trade effluent

· Construction Management: Daily site supervision of cleanroom construction, HVAC, electrical, compressed air, PW/WFI water systems, BMS / EMS. Manage pre-reserved openings, power upgrade, and interface gaps between vendors. Lead safety – PTW, hot work, working at height

· Commissioning & Qualification: Lead facility IQ / OQ/ PQ – air changes, pressure cascade ≥10Pa, temperature / RH control, particle count per ISO 14644-1, recovery test. Qualify chemical exhaust system, scrubber efficiency ≥99%, toxic gas monitoring and alarms, eyewash / safety shower

· Validation Support: Drive facility, utility and cleanroom validation and ensure facility meets GMP requirements for chemical handling. Support EMS / BMS validation, alarm management

· Operations & Maintenance: Establish preventive maintenance, calibration, and critical spare parts program for HVAC, scrubber, exhaust fans, BMS sensors. Manage contractors for maintenance and filter replacement

· EHS & Office Expansion: Own EHS SOPs for chemical handling, spill response, waste disposal. Lead setup of additional office unit – power, data, partition, separation from GMP area

· Budget & Schedule Control: Involve facility works, punch list closure, and taking-over documentation

Requirements

· Bachelor Degree in Mechanical / Electrical / Chemical Engineering or related fields

· More than 10 years’ experience in GMP facility engineering in medical device, pharma or biotech. Must have cleanroom project experience in Singapore

· Strong knowledge of HVAC, cleanroom design per ISO14644, cGMP, and chemical exhaust / scrubber systems for corrosive / toxic chemicals

· Proven experience with Singapore regulatory submissions – NEA, SCDF, BCA, PUB, JTC. Direct experience with Glutaraldehyde /Formaldehyde handling is a major plus

· Experience managing turnkey contractors, reviewing P&ID, layout drawings, and leading SAT / IQ/OQ

· Knowledge of BMS / EMS, calibration, and EHS regulations

· Independent, hands-on, strong coordination and problem-solving skills