ROLE OVERVIEW
The Facilities & Compliance Engineer is responsible for the operation and maintenance of site facilities within a GMP manufacturing environment, with a strong emphasis on regulatory compliance. This role owns facilities-related SOPs, supports audit readiness, and manages Non-Conformance (NC) and CAPA processes, while overseeing contractor and vendor performance across facilities and soft services.
KEY RESPONSIBILITIES
- Manage key equipment/systems including architectural & building maintenance, clean room maintenance, fire protection systems, painting, docks, grounds, pest control, staff amenities, janitorial services, cGMP cleaning and sanitization, and gowning services
- Own facilities-related SOPs, including authoring, revising, and driving continuous improvement
- Own facilities services-related Non-Conformance (NC) and Corrective Action and Preventive Action (CAPA)
- Provide support in preparation of audit room and war room, and ensure facility readiness for internal and regulatory audits
- Partner with vendors, establish KPIs, and perform audits for vendor service contracts to ensure performance against SLA
- Supervise and monitor contractor performance in accordance with established KPIs
- Maintain facilities work orders relating to routine and non-routine facilities maintenance
- Maintain high standards of cleanliness across zones in compliance with QA requirements
- Coordinate and manage the pest control service program, including follow-up on incidents and investigations
- Attend SQDIP and production coordination meetings as required
- Provide training as required and maintain all records necessary to satisfy SOPs and GxP requirements
- Partner with EHSS to develop and manage sustainability initiatives
- Manage facility improvement works and support facilities-related cost saving projects
- Oversee facilities soft services including couriers, stationery, meeting rooms, cafe/pantry operations, and bus services
- Participate actively in the site emergency response team and relevant EHS training
- Support site activities and engagement initiatives across the plant
QUALIFICATIONS & EXPERIENCE
- Bachelor's degree in Engineering, Facilities Management, or related field
- Minimum 5 years of engineering, operations, or facilities experience within a GMP-regulated environment
- Strong working knowledge of GMP/GDP concepts and their practical application in a facilities context
- Demonstrated experience authoring or revising SOPs (not limited to executing them)
- Prior involvement in internal or regulatory audits (e.g. FDA, EU GMP, client/internal QA audits)
- Knowledge of NC/CAPA and Change Control processes, engineering documentation, drawing or records management
- Experience managing contractors and vendors
- Good interpersonal and communication skills with high computer literacy
- Strong customer service focus and professional disposition
