Executive, Process Maintenance

**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**
- 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
- 1 - 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
- For plant administration, must be willing to work in Bandar Enstek, Negeri Sembilan.

**Job Types**: Full-time, Permanent

Pay: RM2,500.00 - RM4,500.00 per month

**Benefits**:

- Free parking
- Health insurance

Schedule:

- Monday to Friday

Supplemental Pay:

- Performance bonus

Ability to commute/relocate:

- Bandar Baru Enstek: Reliably commute or planning to relocate before starting work (prefer