Position Summary

The incumbent will be responsible for the installation, operation, maintenance, and continuous improvement of utility and engineering systems within the manufacturing facility. The ideal candidate should possess more than 10 years of experience in utility systems, maintenance, and engineering projects, preferably within the pharmaceutical or food manufacturing industry. The role requires strong technical expertise, leadership capability, and project management experience to ensure reliable operations, regulatory compliance, and successful project execution.

Key Responsibilities

Utility Systems & Maintenance Management

• Manage the operation and maintenance of engineering systems, including HVAC, water systems, utilities, process engineering equipment, instrumentation, and electrical systems.
• Monitor and review daily engineering activities to ensure optimal system performance, preventive actions, and minimal unplanned downtime.
• Develop and implement preventive maintenance programs and calibration schedules for utility and engineering equipment.
• Manage spare parts planning, procurement, and inventory control to support maintenance activities and operational continuity.
• Prepare, review, and maintain engineering documentation, including Standard Operating Procedures (SOPs), maintenance records, preventive maintenance schedules, and calibration schedules.
• Drive continuous improvement initiatives to enhance operational efficiency and equipment reliability.

Technical Documentation & Drawings

• Prepare and maintain technical drawings, including facility layouts, AHU schematics, P&IDs, and isometric drawings for water loops, compressed air systems, and steam distribution networks.
• Maintain monthly Quality Risk Management (QRM) records and utility consumption data to support operational monitoring, compliance, and reporting requirements.
• Prepare and review User Requirement Specifications (URS) for engineering equipment and utility systems.
• Prepare qualification protocols and reports, including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Project Responsibilities

Project Planning & Documentation

• Prepare engineering and design documentation for project execution.
• Develop, monitor, and control project schedules and budgets, ensuring projects are delivered on time and within approved costs.
• Prepare material submittals for installation and modification works in accordance with project specifications and requirements.
• Collect, review, and organize vendor documentation throughout project execution and coordinate submissions with the Quality Assurance (QA) team.

Project Execution & Coordination

• Manage day-to-day project activities and ensure achievement of project milestones.
• Execute project plans and monitor progress against defined objectives.
• Identify, assess, and resolve project-related issues while ensuring effective team performance.
• Coordinate with consultants, contractors, and vendor representatives for inspections, approvals, testing, and progress reviews.
• Ensure engineering projects comply with safety, quality, and regulatory requirements.

Audit & Regulatory Compliance

• Support and participate in customer, internal, and regulatory audits.
• Ensure compliance with cGMP requirements, Quality Management Systems (QMS), and company procedures.
• Prepare and maintain engineering documentation required for audit readiness.

Regulatory Audit Exposure

• EU-GMP (European Union Good Manufacturing Practices)
• WHO-GMP (World Health Organization Good Manufacturing Practices)
• Customer Audits
• Internal Audits

Qualifications & Skills

Technical Competencies

• Minimum 10 years of experience in utility systems, maintenance, and engineering projects, preferably within the pharmaceutical or food manufacturing industry.
• Strong knowledge of HVAC, water systems, compressed air systems, steam systems, electrical systems, instrumentation, and engineering documentation.
• Experience in qualification and validation activities (DQ, IQ, OQ, PQ).
• Proficiency in AutoCAD, Microsoft PowerPoint, and other engineering software applications.

Soft Skills

• Strong leadership and team management capabilities; prior managerial experience is preferred.
• Good communication and interpersonal skills.
• Ability to work effectively with expatriates and multicultural teams.
• Fluent in Vietnamese with good English communication skills.
• Strong problem-solving and project coordination skills.

Stakeholder Management & External Coordination

• Communicate and coordinate effectively with contractors and service providers at site.
• Liaise with overseas vendors regarding technical support, equipment, and project requirements.
• Maintain effective working relationships with Dong Nai Industrial Zone authorities and neighboring factory utility managers to support operational and project activities.