Senior Executive, Utility Engineering

NOVUGEN PHARMA (MALAYSIA) SDN. BHD.; Nilai; On-site; MYR 60,000 - 90,000; Full time

Job summary

Novugen is seeking a Senior Executive, Utility Engineering to support operation, maintenance and compliance of utility equipment in its pharmaceutical manufacturing facility in Malaysia. You will participate in installation, testing, and commissioning of systems such as air compressors, purified water, HVAC, BMS, EMS, and be involved in qualification/validation activities.

The role requires coordinating maintenance, repairs, SOPs, and GMP/QMS adherence, with focus on timely, compliant

Qualifications

• Must possess a Degree in Mechanical, Electrical, Instrumentation Engineering or equivalent.
• 3–5 years of relevant working experience as a Facilities/Utilities Maintenance Engineer in GMP environment.
• Experience in Water System and HVAC is a plus.
• Experience in Pharma, FMCG or Healthcare industries is an advantage.
• Basic to intermediate knowledge of GMP, QMS, and regulatory requirements for pharmaceutical manufacturing.
• Experience in equipment validation (IQ, OQ, PQ) and troubleshooting utility systems is an advantage.
• Basic to intermediate knowledge of Clean Utilities such as Purified Water System, Compressed Dry Air System, Gases Distribution and HVAC System.
• For plant administration, willing to work in Bandar Enstek, Negeri Sembilan.

Responsibilities

• Responsible for operation, maintenance and compliance of utility equipment (air compressors, purified water system, HVAC, BMS, EMS).
• Coordinate installation, testing and commissioning of water systems, air compressors, HVAC, BMS & EMS.
• Participate in qualification and validation activities (IQ, OQ, PQ).
• Keep equipment operational by coordinating maintenance and repair services.
• Identify faults, investigate production problems and repair equipment quickly.
• Liaise with Procurement for spare parts and consumables.
• Prepare and maintain SOPs for utility equipment and ensure adherence.
• Support GMP and QMS compliance including Change Control and QRA.

Skills

Mechanical engineering

Electrical engineering

Instrumentation

GMP knowledge

Quality management

Regulatory awareness

Coordination

Education

Bachelor’s in Mechanical/Electrical/Instrumentation Engineering

Tools

Water systems

HVAC

Job description

Novugen is one of Southeast Asia's fastest-growing, research-driven multinational pharmaceutical companies. Headquartered in Malaysia, it is a wholly owned subsidiary of SciTech International, a UAE-based group with more than 30 years of global pharmaceutical expertise. Specialising in complex, technology-intensive and high-barrier generics, Novugen is one of ASEAN’s pioneering pharmaceutical companies with integrated capabilities spanning advanced formulation research and development, manufacturing, and global commercialisation.

Its Malaysian facilities include the country’s first USFDA-approved general pharmaceutical manufacturing facility and the region’s first USFDA-approved high-containment oncology manufacturing facility, both Halal-certified by JAKIM.

With a global presence across the United States, ASEAN, CIS, the Middle East and Latin America, Novugen has differentiated capabilities in first-to-market and day-one launches. In 2024, it became Southeast Asia’s first pharmaceutical company to export locally manufactured oncology generics to the United States.

Driven by scientific rigour and an unwavering commitment to quality, Novugen is dedicated to accelerating access to affordable, high-quality medicines and improving lives worldwide.

About the role

The Senior Executive, Utility Engineering will support the operation, maintenance, and compliance of utility equipment in our pharmaceutical manufacturing facility. The role involves assisting in the installation, testing, and commissioning of systems such as air compressors, purified water systems, HVAC, BMS, EMS, and other utility equipment. The successful candidate will participate in qualification and validation activities (IQ, OQ, PQ), coordinate maintenance and repairs, and ensure adherence to Good Manufacturing Practice (GMP) and Quality Management System (QMS) standards while maintaining operational efficiency and compliance.

Key Responsibilities

• Responsible in managing the utility equipment related to air compressor, purified water system, pre-treatment system, potable hot water system, potable ambient water system, HVAC, BMS & EMS.
• Handle and participate in the installation, testing and commissioning of water system, air compressor, HVAC, BMS & EMS
• Participate in qualification and validation activities of utility equipment (IQ, OQ, PQ)
• To keep equipment operational by coordinating maintenance and repair services, following manufacturer’s instructions and established procedures.
• Identify faults, investigate production problems, and repair equipment quickly and efficiently.
• Liaise with Procurement team and supplier in purchasing any spare parts, measuring devices, and consumable items related to utility operations.
• Prepare and maintain SOP for utility equipment including water system, air compressor, chiller, AHU, BMS & EMS and ensure the SOP are adhered all the time.
• Practice and implement Good Manufacturing Practice (GMP) and Quality Management System (QMS) related to activities done at utility equipment including Change Control, Deviation, Quality Risk Assessment (QRA), etc.
• To prepare Preventive Maintenance (PM) checklist for utility system and ensure the implementation of PM according to the PM Master List.
• Ensure implementation of HSE.
• Ensure all aspects of GMP compliance with the work respect to Engineering procedures and cGMP requirements.
• Ensure timely completion of assigned training and maintenance of individual employee training file.
• Perform other ad hoc tasks and related duties as assigned by management from time to time, based on company needs.

About You

• Must possess a Degree in Mechanical, Electrical, Instrumentation Engineering or equivalent and Engineering related competency certificate.
• 3-5 years of relevant working experience as a Facilities/Utilities Maintenance Engineer preferably in Good Manufacturing Practices (GMP) environment
• Relevant technical training and experience in Water System and HVAC are a plus
• Experienced in working for Pharma, FMCG and/or Healthcare industries will be added advantage
• Basic to intermediate knowledge of GMP, QMS, and regulatory requirements for pharmaceutical manufacturing.
• Experience in equipment validation (IQ, OQ, PQ) and troubleshooting utility systems is an advantage
• Basic to Intermediate knowledge of Clean Utilities such as Purified Water System, Compressed Dry Air System, Gasses Distribution and HVAC System
• Physical stamina and the ability to work in various environmental conditions
• Strong mechanical aptitude, problem-solving and cost management mindset.
• Demonstrated strong coordination and collaboration skills through effective teamwork and clear communication.
• High level of integrity and professionalism.
• Adaptable to changing priorities and able to manage multiple stakeholders effectively.
• Strong intrapreneurial skills and mindset from start up to established organization
• Proficient in Microsoft Office Suite
• For plant administration, must be willing to work in Bandar Enstek, Negeri Sembilan.

Novugen specializes in venturing into strategic healthcare businesses and developing world-class healthcare facilities across the globe. With operations in multiple countries across continents, our global presence and expertise empower us to meet the complex challenges of delivering hard-to-source, technology-intensive pharmaceutical products to market. Our manufacturing facilities are the first USFDA-approved pharmaceutical manufacturing facilities in Malaysia and Southeast Asia. We are also the first pharmaceutical company in the region to be vertically integrated from R&D to manufacturing.

Novugen specializes in venturing into strategic healthcare businesses and developing world-class healthcare facilities across the globe. With operations in multiple countries across continents, our global presence and expertise empower us to meet the complex challenges of delivering hard-to-source, technology-intensive pharmaceutical products to market. Our manufacturing facilities are the first USFDA-approved pharmaceutical manufacturing facilities in Malaysia and Southeast Asia. We are also the first pharmaceutical company in the region to be vertically integrated from R&D to manufacturing.