Kerja Sepenuh Masa Senior Executive, Process Maintenance, Gaji tinggi MYR 3,000 di Novugen Pharma Selangor - Maukerja

About us

Novugen is a wholly owned subsidiary of SciTech International, a UAE-based group with over 30 years of experience in the healthcare industry. We specialize 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 in Bandar Enstek, Negeri Sembilan, 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, giving us greater control over the supply chain and reflecting our commitment to meeting a wide range of stringent regulatory standards.

At Novugen, we are united by a shared vision, with a team of talented individuals from diverse backgrounds and nationalities working together towards one common goal. We are driven by a passion for science and innovation, striving to accelerate the launch of pharmaceuticals that lack robust generic alternatives due to their complexity. Our continued investment in R&D and dedication to excellence aim to provide early access to affordable, high-quality medicines, impacting lives across the world.

Together, we are shaping the future of healthcare and changing lives everywhere.

About the role

To 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, 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.

• Assist in managing and maintaining utility equipment, including air compressors, purified water systems, pre-treatment systems, potable hot and ambient water systems, BMS, and EMS
• Support installation, testing, and commissioning of water systems, air compressors, BMS, and EMS
• Participate in qualification and validation activities of utility equipment (IQ, OQ, PQ)
• Ensure timely maintenance and repair of equipment by following manufacturer guidelines and SOPs
• Identify faults, investigate production-related equipment issues, and execute quick and effective repairs
• Work closely with the Procurement team and suppliers to source spare parts, measuring devices, and consumables
• Assist in developing, updating, and enforcing SOPs related to utility equipment, ensuring compliance at all times
• Support GMP and QMS requirements, including Change Control, Deviation, and Quality Risk Assessment (QRA)
• Assist in executing Preventive Maintenance (PM) checklists for utility systems as per the PM Master List
• Ensure compliance with Data Integrity principles and maintain accurate documentation
• Promote and adhere to Health, Safety, and Environment (HSE) regulations within the Engineering Department
• Conduct training sessions on SOPs and regulatory requirements as necessary
• Provide technical support and updates on project status, challenges, and progress to senior management and cross-functional teams as required
• Stay updated with industry trends, regulatory changes, and technological advancements, facilitating knowledge transfer within the team for continuous improvement
• Any other ad hoc tasks assigned by the management

About You

• Must possess a Diploma/ Degree in Mechanical, Electrical, Instrumentation Engineering or equivalent and Engineering related competency certificate.
• Related working experience as a Facilities/Utilities Maintenance Engineer preferably in Good Manufacturing Practices (GMP) environment
• Minimum 3 years of relateable experience, fresh graduates encouraged to apply.
• Relevant technical training and experience in Water System is 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
• 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
• Must be willing to work in Bandar Enstek, Negeri Sembilan.

Job Types: Full-time, Permanent

Pay: From RM3,000.00 per month

Benefits:

• Free parking
• Health insurance

Application Question(s):

• Are you familiar with GMP requirements? If yes, from which experience?
• How long is your notice period?
• What is your expected salary (RM)?

Experience:

• both, electrical and mechanical: 4 years (Preferred)
• Production machine maintenance: 4 years (Preferred)

Work Location: In person