Facilities Manager ( GMP )

Job Summary:

• Manage the day-to-day operations of pharmaceutical manufacturing, laboratory, warehouse, and office facilities to ensure a safe, compliant, and efficient working environment.
• Ensure facilities operations are conducted in compliance with regulatory requirements, including Good Manufacturing Practice (GMP), Good Distribution Practice (GDP) where applicable, and company Quality Management Systems.
• Lead site facilities teams and contractors to maintain critical building systems such as HVAC, cleanrooms, utilities, water systems, electrical, fire protection, and building infrastructure.
• Partner closely with Quality Assurance, Engineering, EHS, Validation, Production, and other stakeholders to support uninterrupted pharmaceutical operations.
• Ensure all facilities-related activities, maintenance programs, documentation, and change controls comply with GMP standards and audit requirements.
• Support internal, customer, and regulatory inspections and ensure timely closure of observations and corrective actions.
• Drive continuous improvement initiatives to enhance compliance, operational reliability, safety, and cost efficiency.

Key Responsibilities:

• GMP & Regulatory Compliance
• Ensure all facility operations and maintenance activities are performed in accordance with GMP requirements and site quality procedures.
• Maintain facility documentation, SOPs, maintenance records, calibration records, and logbooks in compliance with GMP standards.
• Participate in investigations, deviation management, CAPA implementation, change control, and risk assessments related to facilities systems.
• Support regulatory inspections, customer audits, and quality audits.
• Ensure contractors working within GMP areas comply with site quality, safety, and contamination control requirements.
• Critical Utilities & Infrastructure Management
• Oversee operation and maintenance of:

1. HVAC and cleanroom systems
2. Building Management Systems (BMS)
3. Electrical distribution systems
4. Compressed air systems
5. Water systems (Purified Water, WFI where applicable)
6. Critical process utilities
7. Fire protection systems
8. Emergency power systems

• Monitor facility performance and ensure compliance with environmental and cleanroom parameters.
• Quality & Risk Management
• Work closely with QA to ensure facility systems remain in a validated state.
• Support qualification and validation activities for facilities and utilities.
• Conduct routine facility inspections and audits to identify compliance gaps.
• Ensure timely execution of preventive maintenance programs to minimize operational risks.

Key Result Areas:

• 100% compliance with GMP, Quality, EHS, and regulatory requirements.
• Successful support of internal, customer, and regulatory audits.
• High uptime and reliability of critical utilities and facility systems.
• Effective management of facility maintenance and contractor performance.
• Timely closure of deviations, CAPAs, change controls, and audit findings.
• Achievement of customer satisfaction, operational efficiency, and financial targets.
• Continuous improvement of facility performance, compliance, and sustainability initiatives.
• Have thorough understanding of the contract and ensure that the contractual obligations are delivered and meet Customer Satisfaction expectation
• Work closely with Customer, peers and subordinates to foster close working relationship
• Provides leadership to site team to ensure operational excellence is continually achieved
• Staff development and training to improve productivity & competencies
• Role out the branding policy and follow as per specification
• The timely preparation and submission of payroll and notice of change forms.
• Preparation of monthly and quarterly or yearly report
• Responsible and adherence to all Safety, Health and Environment Procedures and Reporting
• Customer retention and to participate in contract renewal.
• Staff training and retention
• Ensure all billing on time (Base and Ad-hoc works)
• Acquire more Ad-hoc works on site to increase business volume.
• Meeting projected gross margin targets

Knowledge, Skill and Abilities Required:

• Bachelors degree in engineering, engineering technology.
• Minimum 5-8 years of Facilities Management experience within a pharmaceutical, biotechnology, medical device, life sciences, or regulated manufacturing environment.
• Proven experience managing facilities within a GMP-regulated environment is mandatory.
• Experience supporting pharmaceutical manufacturing facilities, laboratories, cleanrooms, and critical utilities.
• Experience handling regulatory inspections, audits, and compliance programs.
• Strong interpersonal relations ability, excellent oral and written communications skills
• Excellent time management and teamwork skills
• Commitment to continuous improvement and best practice
• Excellent grooming and personal hygiene standards
• Self-motivated and lateral thinking
• Must be computer literate in Microsoft Office products (Word, Excel, Outlook)
• Excellent English written and verbal communication skills.