Malaysia Site construction Manager

Construction Manager – Fit-Out (Medical Device CDMO Manufacturing Site)

Location: Senai, Johor, Malaysia

Employment Type: Fixed-Term Project (Potential for Long-Term Opportunity)

Salary: RM15k to RM20k+ Per month (Negotiable)

About the Opportunity

Our client is a Singapore-headquartered engineering and manufacturing organisation undertaking a major expansion of its medical device manufacturing operations in Malaysia.

They are seeking an experienced Construction Manager to lead the fit-out and delivery of a new state-of-the-art manufacturing facility in Senai, Johor. This is a high-impact project involving the construction of cleanrooms, controlled manufacturing environments, laboratories, production areas, utilities, and supporting infrastructure for a regulated medical device manufacturing operation.

The successful candidate will work closely with Engineering, Quality, Validation, Operations, EHS, consultants, and contractors to ensure the project is delivered safely, on schedule, within budget, and in full compliance with GMP and medical device regulatory requirements.

Key Responsibilities:

Construction & Project Management

• Lead all on-site construction and interior fit-out activities.
• Manage contractors, subcontractors, consultants, suppliers, and vendors throughout the project lifecycle.
• Ensure delivery against project scope, quality standards, schedule, and budget.
• Monitor progress, identify project risks, and implement mitigation plans.
• Coordinate daily construction activities and site operations.

Cleanroom & Regulated Facility Delivery

• Oversee the construction of ISO-classified cleanrooms and controlled manufacturing environments.
• Manage installation of HVAC systems, clean utilities, contamination control systems, pressure cascades, humidity, and temperature-controlled environments.
• Ensure facilities meet GMP standards and support medical device manufacturing operations.
• Partner with Validation and Quality teams to ensure readiness for IQ/OQ/PQ qualification activities.

Engineering Coordination

• Review engineering drawings, specifications, and design revisions.
• Coordinate closely with architects, engineers, and design consultants.
• Ensure construction aligns with engineering intent and regulatory requirements.
• Provide technical input on construction methodology, sequencing, layouts, and material selection.

Compliance & Quality

• Ensure compliance with GMP, ISO 13485, applicable medical device regulatory expectations, building regulations in Malaysia, and EHS requirements.
• Support regulatory inspections, customer audits, and qualification activities.
• Maintain complete construction and quality documentation.

Health, Safety & Environment

• Promote a strong safety culture across all project activities.
• Ensure contractors comply with site safety procedures and statutory regulations.
• Conduct regular safety inspections, audits, and risk assessments.

Cost & Schedule Management

• Manage project budgets, contractor claims, variation orders, and cost control.
• Develop and maintain project schedules and critical path activities.
• Coordinate inspections, commissioning, mechanical completion, and project handover.

Stakeholder Management

• Act as the primary on-site representative throughout construction.
• Coordinate with Engineering, Operations, Manufacturing, Quality, Validation, IT, contractors, consultants, and project leadership.
• Provide regular progress updates to senior management.
• Liaise with local authorities and regulatory bodies where required.

Requirements:

Education

• Bachelor's Degree in Civil Engineering, Mechanical Engineering, Construction Management, or a related discipline.

Experience

• 10–15+ years of construction or project management experience.
• Minimum 5 years managing projects within regulated industries such as Medical Devices, Pharmaceuticals, Biotechnology, Life Sciences, or Semiconductor manufacturing.
• Proven experience delivering cleanroom or GMP manufacturing facilities.
• Strong knowledge of HVAC systems, clean utilities, and controlled environment construction.
• Experience with CDMO or contract manufacturing facilities is advantageous.
• Familiarity with construction regulations in Malaysia and permitting processes is preferred.

Key Competencies

• Construction Project Leadership
• Site & Contractor Management
• Cleanroom & GMP Facility Delivery
• Cost & Budget Management
• Project Planning & Scheduling
• Risk Management
• Regulatory Compliance
• Stakeholder Management
• Strong Communication & Leadership Skills