About
The Maintenance Engineer (Utilities & Building Facilities) will be responsible for the reliability and compliance of utility systems in the pharmaceutical manufacturing plant. This includes maintenance, troubleshooting, and optimization of systems like HVAC, boilers, and water systems, while adhering to GMP, FDA, ISO, and safety regulations. The role also involves contributing to utility design reviews and project commissioning.
Responsibilities
Utility Systems Maintenance & Reliability:
- Perform maintenance (preventive, predictive, corrective) on utility systems (HVAC, water, air, chillers, waste treatment).
- Develop and manage maintenance schedules for system availability and compliance.
- Optimize energy and water usage to improve efficiency and sustainability.
- Manage contractors, maintain spare parts inventory, and coordinate procurement.
Facilities & Building Maintenance:
- Oversee maintenance of building amenities (cleanrooms, fire protection, security, infrastructure).
- Ensure HVAC systems meet required temperature, humidity, and air quality standards.
- Coordinate with contractors for facility maintenance, repairs, and improvements.
Regulatory Compliance & Documentation:
- Ensure compliance with GMP, FDA, ISO, and EHS regulations, and maintain records for audits.
- Support audits with documentation, technical explanations, develop and update maintenance SOPs.
Continuous Improvement & Sustainability Initiatives:
- Implement projects to improve utility efficiency, reduce energy costs, and support sustainability initiatives (energy recovery, water recycling).
- Conduct root cause analysis (RCA), reliability-centered maintenance (RCM), and support the installation, commissioning, and validation of new utility systems.
Safety & Compliance:
- Ensure maintenance activities comply with safety, GMP, and environmental regulations, and conduct risk assessments with preventive measures.
- Provide training and mentorship to maintenance technicians.
Project Support and Commissioning:
- Participate in the review and commissioning of utility systems during project phases and provide technical support for Factory Acceptance Tests (FAT).
- Support installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ).
Qualifications
- Bachelor Degree in Mechanical Engineering, Electrical Engineering, or a related field.
- Minimum 8 years of experience in utility and facility maintenance within a pharmaceutical or regulated manufacturing environment.
- Strong knowledge of HVAC, boilers, chillers, purified water systems, and building automation systems.
- Experience with Computerized Maintenance Management Systems (CMMS).
- Familiarity with regulatory compliance requirements such as GMP, FDA, PIC/S, and local safety regulations.
- Experience in lean maintenance, TPM, Six Sigma, Industry 4.0 trends, and commissioning/validation of utility systems.
- Able to work in a controlled cleanroom environment, with the ability to lift and handle on-call or shift work.
