Senior Utilities Engineer – GMP Pharma Operations

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 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