Facility & Utility Lead

Job Responsibilities:

• Lead the Facilities and Utilities team in the operation, maintenance, and reliability management of both GMP and non-GMP facilities.
• Ensure all facility operations, maintenance, calibration, and engineering activities comply with applicable regulatory, quality, and company requirements.
• Oversee facility management, including daily operations, preventive maintenance (PM), asset reliability, to ensure uninterrupted support for site manufacturing and business operations.
• Lead the Engineering team in supporting capital projects, providing engineering input for facility and utility design, and ensuring successful startup and commissioning of new facilities and equipment.
• Ensure full compliance with Environmental, Health, and Safety (EHS) requirements within the Engineering department and promote a strong safety culture.
• Drive continuous improvement initiatives to enhance facility performance, operational efficiency, equipment reliability, and facility design.
• Manage departmental budgets, including operating expenses (OPEX) and capital expenditures (CAPEX), while identifying and implementing cost-saving opportunities.
• Foster a high-performance, PROUD culture within the Engineering team, promoting accountability, engagement, innovation, and operational excellence.
• Establish and maintain an effective spare parts management program, ensuring critical spare parts availability through appropriate classification, inventory optimization, and safety stock management.
• Lead talent acquisition, training, coaching, performance management, succession planning, and employee development in alignment with company and Human Resources strategies.
• Facilitate regular deviation review meetings to strengthen root cause analysis capabilities, improve problem-solving effectiveness, and reduce recurring deviations.
• Monitor engineering-related quality system activities, including deviations, CAPAs, change controls, and maintenance compliance, ensuring timely closure and regulatory compliance.
• Promote and implement Lean Manufacturing, TPM, and 5S principles to improve operational efficiency and workplace organization.
• Establish equipment criticality classifications and maintenance strategies based on risk assessment methodologies to optimize reliability and compliance.
• Support site inspections, audits, and regulatory assessments, ensuring Engineering readiness and compliance at all times.
• Accomplish other tasks assigned by line manager

Requirement：

• Bachelor's degree or above in engineering, majoring in mechanical, electrical, or related fields with min 15 years of experiences.
• Good knowledge of GMP.
• Experience in GMP certification, FDA cGMP or EU GMP certification audit is preferred
• Project management and PMP certification preferred.
• Lean manufacturing mindset and knowledge preferred.
• Familiarity with the Maximo maintenance management system preferred.