Facilities Manager(GMP)

*GMP certification/experience is mandatory*

Job Summary:

· Manage the day-to-day operations of pharmaceutical manufacturing, 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:

HVAC and cleanroom systems

Building Management Systems (BMS)

Electrical distribution systems

Compressed air systems

Water systems (Purified Water, WFI where applicable)

Critical process utilities

Fire protection systems

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

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