Associate Manager, Project cum Facility Engineering

Novugen Pharma; Seremban; On-site; MYR 100,000 - 150,000; Full time

Job summary

A leading pharmaceutical company in Negeri Sembilan is looking for an Associate Manager, Project cum Facility Engineering. This role involves managing engineering projects and facility operations within an OSD manufacturing environment. The ideal candidate will have a Bachelor's degree and a minimum of 5 years of experience in a GMP setting. Key responsibilities include overseeing engineering operations, coordinating installations, and ensuring compliance with regulatory standards. The position offers opportunities to lead initiatives that enhance operational efficiency.

Qualifications

• Minimum 5 years of working experience in OSD GMP environment.
• Strong knowledge of project management.
• Experience with GMP compliance and regulatory guidelines.

Responsibilities

• Plan, execute, and manage capital engineering projects.
• Oversee facility engineering operations and ensure reliable performance.
• Coordinate equipment installation, commissioning, and qualification activities.

Skills

Project management

Leadership skills

GMP compliance

Problem-solving

Collaboration skills

Education

Bachelor’s degree in electrical, Electronics, or Mechatronics

Job description

Associate Manager, Project cum Facility Engineering

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

We are seeking a highly motivated and experienced professional for the Project cum Facility Engineering role to support and manage engineering projects and facility operations within an Oral Solid Dosage (OSD) manufacturing environment. The role is responsible for planning, execution, and oversight of capital projects, facility and infrastructure systems to ensure safe, compliant, and efficient manufacturing operations. This position requires strong technical expertise in pharmaceutical facilities, equipment installation, and regulatory compliance, along with the ability to coordinate cross-functional teams and external contractors. The incumbent will play a critical role in maintaining facility reliability, optimizing engineering systems, and supporting continuous improvement initiatives in line with GMP and regulatory standards.

Key Responsibilities

• Plan, execute, and manage capital engineering projects, including facility expansion, equipment installation, modification, and technology upgrades.
• Oversee facility engineering operations, ensuring reliable performance of building systems, and infrastructure.
• Coordinate equipment installation, commissioning, and qualification (IQ/OQ/PQ) activities in collaboration with QA, Production, and Validation teams.
• Ensure GMP compliance of facilities and engineering practices, and support regulatory inspections and audits (USFDA, NPRA, etc.).
• Develop and execute preventive and breakdown maintenance plans to minimize downtime and ensure operational continuity.
• Prepare and review engineering documentation, including URS, DQ, SOPs, change controls, risk assessments, and validation protocols.
• Lead and coordinate contractors, vendors, and service providers, ensuring adherence to safety, quality, timelines, and budget requirements.
• Monitor and control project budgets, timelines, and resource utilization, ensuring cost-effective execution.
• Implement EHS and safety standards, ensuring safe work practices, compliance with statutory requirements, and incident prevention.
• Support continuous improvement initiatives by identifying opportunities for energy optimization, process efficiency, and facility enhancement.
• Collaborate with cross-functional teams to support production targets, troubleshooting engineering issues impacting OSD manufacturing operations.
• Maintain compliance with statutory, legal, and environmental regulations related to facility operations and engineering activities.

About you

• Bachelor’s degree in electrical, Electronics, Mechatronics or equivalent.
• Minimum 5 years of related working experience in OSD Good Manufacturing Practices (GMP) environment.
• Strong knowledge of Project management.
• Proven leadership and team management skills.
• Experience with GMP compliance and regulatory guidelines.
• 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.
• For plant administration, must be willing to work in Bandar Enstek, Negeri Sembilan.