Facilities Engineer

Responsabilidades

• Maintains compliance with GMP, FDA, and other applicable regulations in Facilities & Utilities documentation.
• Ensures consistent, accurate, and up-to-date operational documentation.
• Safeguards product quality, patient safety, personnel and equipment safety.
• Standardizes the format, technical content, and terminology of SOPs.
• Helps reduce deviations, audit observations, and operational downtime.
• Assesses existing documentation gaps and gathers the technical information needed to address them.
• Performs “walkdowns” and field verifications of Facilities & Utilities systems.
• Verifies the operability of emergency power generators and other critical backup systems (UPS, electrical distribution) during field walkdowns.
• Covers both GMP-supporting facility systems (e.g., purified water, cleanroom HVAC, HEPA filtration, differential pressure) and non-GMP systems (e.g., BMS, electrical power, fire protection) in verifications and documentation.
• Develops new SOPs and reviews/updates existing SOPs.
• Coordinates reviews with the Engineering, Facilities, QA, EHS, and Validation teams.
• Supports Change Control and Document Control processes.
• Maintains trackers and status reports for documentation in progress.
• Participates in technical meetings and project progress presentations.
• Works in parallel with another engineer on the team to meet the established schedule.
• Performs verification work at client facilities and drafting/documentation compilation work at the SPS office in Guaynabo.
• Coordinates weekly with the client team according to project priorities.
• Uses Company-authorized Artificial Intelligence (AI) tools to support documentation drafting, technical research, and productivity, in compliance with SPS's and its clients' confidentiality and information security policies.
• Performs other duties related to the position as assigned by management.

Requisitos

• Bachelor's degree in Mechanical, Electrical, Chemical Engineering, or a related discipline.
• Minimum of three (3) to seven (7) years of experience in Facilities/Utilities within a regulated industry.
• Experience in technical SOP writing (standard operating procedures).
• Knowledge of GMP, FDA regulations, and document control.
• Ability to interpret drawings, manuals, and technical documentation.
• Proficiency in Microsoft Office.
• Bilingual: advanced Spanish and English, needed to coordinate with both Puerto Rico and California teams.
• Practical knowledge and experience working with both GMP-supporting and non-GMP facility systems, including but not limited to:
• Knowledge and prior experience with water systems (potable water, DI/purified water, potable water distribution, sanitary and wastewater, wastewater pre-treatment, stormwater drainage).
• Knowledge and prior experience with HVAC and environmental control systems (air handling units, cleanroom HVAC, HEPA filtration, differential pressure, temperature and humidity control).
• Knowledge and prior experience with process utilities (process vacuum, process gases such as nitrogen and argon, plant steam, cooling water/cooling towers/chillers, refrigeration).
• Knowledge and prior experience with electrical and power systems (electrical distribution, transformers/switchgear/electrical panels, emergency generators, UPS, lighting systems, diesel fuel storage and distribution) — including verification of their operability (e.g., functional testing of emergency generators).
• Knowledge and prior experience with building management and maintenance systems (Building Management System – BMS, preventive maintenance, Facilities change control).
• Knowledge and prior experience with fire protection and alarm systems.
• Knowledge and prior experience with general facility systems (elevators/freight lifts, building envelope/roofing, automatic/roll-up doors, dock equipment, cafeteria utilities, facilities cleaning and maintenance).
• Prior experience supporting projects in regulated industries, preferably medical devices, pharmaceutical, or biotechnology.
• Certification or training in GMP documentation or technical writing (recommended, not required).
• Willingness to travel to client sites outside Puerto Rico, including California, as business needs require.

Beneficios

• Plan médico
• Plan de retiro (401k)
• Licencia por enfermedad
• Bonos
• Plan dental
• Vacaciones pagas
• Uniformes provistos

Resumen