Position SummaryWe are seeking an experienced
Facilities Subject Matter Expert (SME) to support engineering and manufacturing operations at Carolina, PR. The selected candidate will provide technical leadership for facility systems, utilities, infrastructure, and engineering projects while ensuring compliance with cGMP, safety, and engineering standards.
The role requires close collaboration with Engineering, Operations, Maintenance, Quality, Validation, EHS, and contractors to ensure reliable facility operations and successful execution of engineering initiatives.
Key Responsibilities- Provide technical support for facility systems and utility operations.
- Serve as the Facilities SME for engineering projects, equipment modifications, and operational improvements.
- Support HVAC, clean utilities, building infrastructure, and facility systems.
- Troubleshoot facility-related issues and perform root cause investigations.
- Participate in Change Controls, Deviations, CAPAs, Risk Assessments, and engineering investigations.
- Review engineering documentation, technical reports, SOPs, and project deliverables.
- Coordinate contractors and support commissioning, qualification, and startup activities.
- Drive continuous improvement initiatives while ensuring compliance with cGMP, safety, and environmental requirements.
Qualifications- Bachelor's degree in Mechanical, Electrical, Chemical, Civil, or related Engineering discipline.
- Minimum 5 years of facilities engineering experience within the pharmaceutical, biotechnology, or medical device industry.
- Strong knowledge of facility systems, utilities, cGMP regulations, investigations, and change management.
- Experience supporting capital projects, engineering documentation, and cross-functional teams.
- Fully bilingual (English and Spanish).
- Strong technical, communication, and problem-solving skills.
Preferred Qualifications- Professional Engineer (PE) license preferred.
- Experience supporting Lilly or other FDA-regulated pharmaceutical manufacturing facilities.
- Familiarity with commissioning, qualification, validation, and CMMS systems (e.g., Maximo).
