Kerja Sepenuh Masa Senior Executive, Project Management Engineering, Gaji tinggi MYR 4,000 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 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.

5. Risk 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.

7. Continuous Improvement:

- 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.

Pay: From RM4,000.00 per month

Application Question(s):

• Do you have experience managing CAPEX projects from planning/feasibility through installation, commissioning, and handover?
• Please state your notice period.
• What is your salary expectation?

Experience:

• CAPEX project management, or engineering project execution: 4 years (Required)

Work Location: In person