We are seeking a Facitlities Engineer to support the qualification and validation of process equipment, utilities, and controlled environments within a GMP-regulated pharmaceutical manufacturing facility. The role focuses on managing all facilities-related operations, covering building maintenance, soft services, vendor management, and compliance with quality and regulatory standards (e.g., cGMP, GxP).
Key Responsibilities
- Oversee architectural and building maintenance works, including cleanroom maintenance, painting, docks, and grounds.
- Maintain and track facilities work orders for routine and non-routine maintenance.
- Own and manage facilities-related Non-Conformances (NC) and CAPA.
- Manage key systems such as fire protection, security systems, and staff amenities.
- Partner with vendors to establish KPIs and service level agreements (SLAs).
- Maintain documentation and training records in line with regulatory standards.
- Support audit readiness by preparing audit rooms/war rooms and ensuring facility compliance.
- Ensure high standards of cleanliness across all zones in compliance with QA and cGMP requirements.
- Ensure compliance with SOPs, cGMP, and GxP requirements.
- Coordinate schedules for operations, maintenance, and administrative staff.
- Participate in the site emergency response team and EHS-related training.
- Ensure compliance with all safety and environmental regulations.
Requirements
- Bachelor's degree in Facilities Management, Engineering, or related field (preferred).
- Relevant experience in facilities management, preferably in a regulated environment (e.g., pharmaceutical, biotech, or manufacturing).
- Knowledge of cGMP, GxP, and EHS standards.
- Strong vendor management and stakeholder engagement skills.
- Good organizational, problem-solving, and communication skills.
