Facilities Manager(GMP)
Muss:QA/TestLead
*GMP certification/experience is mandatory*
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:
- 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