Smart Precise Solutions

The Facilities Engineer supports Facilities & Utilities projects for our clients in the Medical Devices Industry, covering GMP and non-GMP systems in regulated environments and ensuring compliance with GMP, FDA, and quality requirements. This role is primarily based in Puerto Rico, with travel to other client sites, including California, as business needs require. The engineer performs field verifications, including the operability of emergency generators and other critical systems, develops and updates SOPs, reviews technical documentation, and collaborates with the Engineering, Facilities, QA, EHS, and Validation teams.

Key Responsibilities

• 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.

• Analytical thinking.
• Effective communication.
• Ability to manage multiple projects.
• Regulatory compliance orientation.
• Integrity and professional ethics in handling technical and confidential information.
• Proactivity in identifying improvements to documentation and processes.
• Ability to work with minimal supervision, actively supporting the project team’s goals.

• Meet GMP, FDA, and other applicable regulatory compliance objectives across all documentation developed.
• Keep trackers and status reports for documentation in progress up to date.
• Use Company-provided technology and artificial intelligence tools responsibly and ethically, complying with SPS’s information security, confidentiality, and data protection policies.
• Participate punctually in technical meetings, walkdowns, and weekly coordination calls with the client team.
• Comply with EHS policies and the client facilities’ access and security requirements during field visits.
• Safeguard the confidentiality of the client’s technical, process, and documentation information.
• Complete required training and certifications for the position within established timeframes.
• Promptly communicate to management any delay or risk affecting the project schedule.
• Represent SPS professionally to client personnel and teams.

• 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.

• Availability to work at client facilities for field verifications (“walkdowns”) and technical meetings, as well as at the SPS office in Guaynabo for drafting and documentation compilation.
• Extended computer use for drafting and reviewing technical documentation.
• Availability to comply with access, gowning, and security requirements at the client’s regulated facilities during field visits.
• Occasional exposure to manufacturing environments, cleanrooms, or mechanical/electrical areas during walkdowns.
• Weekly coordination, in person or virtual, with the client team according to project priorities.
• Use of personal protective equipment (PPE) depending on area and task during field verifications; ability to climb stairs, walk for extended periods, and access mechanical/electrical spaces as required during walkdowns.
• Ability and willingness to travel to client sites outside Puerto Rico (e.g., California), including occasional overnight travel.