Facilities Process Engineer

EQVAL Group, Inc. is a company that provides services to the manufacturing industry (Medical Devices, Pharmaceuticals, Biotechnologies, others). We work with an extraordinary group of professionals (employees and contractors) to accomplish the requirements established by our customers, in order to perform and provide a highly effective service.

We are seeking a Facilities Process Engineer to support facilities and CAPEX projects, including HVAC systems, compressed air, utilities, and building automation systems. This role requires strong experience in facilities validation within regulated environments (Pharma, Biotech, or Medical Devices), with hands-on involvement in protocol generation and execution. The position is on-site in Añasco (M–F) with availability for weekends/OT as needed during testing phases.

Key Requirements:

• Bachelor’s Degree in Engineering
• Minimum of 6+ years of experience in Pharma, Biotech, or Medical Devices
• Strong experience in Facilities and Utilities Validation
• Hands-on experience with protocol writing and execution (FAT/SAT, IQ/OQ/PQ)
• Experience with HVAC systems, compressed air systems, and utilities
• Computer System Validation (CSV) experience, particularly with Building Automation Systems
• Knowledge of regulatory requirements (FDA, GMP, ISO, GAMP 5)
• Experience with CAPA, deviations, and non-conformance investigations
• Strong project management and technical writing skills

Key Responsibilities:

• Support facilities validation activities for CAPEX projects, including HVAC, compressed air, and utilities systems
• Generate, execute, and review validation documentation (URS, FRS, SDS, FAT/SAT, IQ/OQ/PQ, reports)
• Participate in the full validation lifecycle, including risk assessments, traceability matrix, and deviation management
• Lead and support non-conformance investigations and CAPA activities
• Perform statistical analysis and develop sampling plans to support validation efforts
• Troubleshoot automation and computer systems during validation activities
• Coordinate with vendors and cross-functional teams for equipment installation and project execution
• Ensure compliance with FDA, ISO, GMP, and other applicable regulations
• Support audits, regulatory submissions, and continuous improvement initiatives
• Monitor validation activities and report project status to ensure timely completion

Benefits:

• Health insurance (Medical, Dental, Vision, Pharmacy)
• Life Insurance
• Paid time off (PTO)
• Holidays
• Professional Growth (Courses and Certifications by EQVAL Academy)
• Referral program
• Productivity incentive