Senior Executive, Project Management

NOVUGEN PHARMA (MALAYSIA) SDN. BHD.; Nilai; On-site; MYR 180,000 - 240,000; Full time

Job summary

NOVUGEN PHARMA (MALAYSIA) SDN. BHD. is seeking an experienced Project Engineer to lead CAPEX projects in a regulated pharmaceutical environment.

You will develop detailed project plans, manage end-to-end lifecycle from feasibility to handover, and ensure URS and GMP compliance across production facilities. The role requires a bachelor’s degree in Engineering and at least 5 years in pharmaceutical project management, with strong stakeholder and vendor management skills.

Qualifications

• Bachelor’s degree in Engineering (Mechanical, Electrical, Chemical or related).
• Minimum 5 years of experience in project engineering, CAPEX project management, or engineering projects.
• Experience in pharmaceutical or regulated manufacturing.
• Experience from feasibility, planning, procurement through installation, commissioning and handover.
• Strong GMP knowledge and regulatory expectations.
• Experience in developing URS, technical specs, drawings, quotations, and vendor proposals.
• Cross-functional stakeholder coordination and communication.

Responsibilities

• Develop comprehensive project plans with timelines, budgets and resources.
• Manage end-to-end lifecycle of CAPEX projects from feasibility to handover.
• Develop and maintain URS for production machines, utilities and facilities.
• Ensure URS compliance with GMP and quality procedures.
• Coordinate reviews with Engineering, Production, QA, Validation and other departments.
• Deliver projects within approved financial parameters.
• Coordinate with vendors/contractors; review proposals and monitor progress.
• Contribute to Lean, Kaizen and continuous improvement initiatives.

Skills

Project management

Risk management

Cross-functional collaboration

Regulatory compliance

Vendor management

Documentation proficiency

Education

Bachelor’s degree in Engineering

Job description

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 eight 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 the 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

1. Project Planning and Execution:

Assist in developing comprehensive project plans, including timelines, budgets, and resource allocations.

Control and monitor the end-to-end lifecycle of CAPEX projects, from feasibility studies to commissioning and handover.

2. Technical Documentation and URS Development:

Develop, review, and maintain User Requirement Specifications (URS) for production machines, utilities, and facility-related projects.

Ensure URS documents comply with GMP requirements and internal quality procedures.

Coordinate technical reviews and approvals with Engineering, Production, QA, Validation, and other relevant departments.

Ensure projects are delivered within approved financial parameters.

3. Regulatory Compliance:

Ensure all projects comply with pharmaceutical industry regulations (e.g., GMP, FDA, EMA).

Maintain documentation and quality assurance records for regulatory audits.

4.Stakeholder Collaboration:

Coordinate with cross-functional teams, including production, quality, procurement, and external contractors.

Communicate project progress and challenges to stakeholders and senior management.

Identify potential risks and develop mitigation strategies.

Address projects promptly to minimize disruptions.

6. Vendor and Contractor Management:

Coordinate with vendors and contractors during project execution

Review technical proposals, quotations, drawings, and specifications.

Monitor contractor activities to ensure compliance with safety, quality, and project requirements.

Track vendor deliverables and overall project performance.

Identify opportunities for process optimization and operational efficiency improvements.

Participate in Lean, Kaizen, and continuous improvement initiatives.

Recommend improvements to project management processes and technical documentation practices.

About you

Bachelor’s Degree in Engineering, preferably Mechanical, Electrical, Chemical, or a related discipline.

Minimum 5 years of relevant experience in project engineering, CAPEX project management, or engineering projects, preferably within the pharmaceutical or regulated manufacturing industry.

Hands-on experience managing projects from feasibility, planning, and procurement through installation, commissioning, and handover.

Strong understanding of GMP requirements, pharmaceutical engineering standards, and regulatory expectations, with experience in preparing and maintaining technical documentation.

Experienced in developing and reviewing URS, technical specifications, drawings, quotations, and vendor proposals for equipment, utilities, and facility-related projects.

Demonstrated ability to coordinate cross-functional stakeholders, including Engineering, Production, QA, Validation, Procurement, and external vendors/contractors.

Strong project management, problem-solving, and risk management skills, with the ability to manage timelines, budgets, and competing priorities.

Good understanding of vendor and contractor management, including monitoring deliverables, quality, safety, and project progress.

Experience in Lean, Kaizen, continuous improvement, or process optimisation would be an added advantage.

Strong communication and interpersonal skills, with the ability to engage effectively with both technical teams and senior stakeholders.

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.