Facilities Process Engineer
About The Position
EQVAL Group, Inc. provides services to the manufacturing industry, including Medical Devices, Pharmaceuticals, and Biotechnologies. The company works with an extraordinary group of professionals to meet customer requirements and provide highly effective service. They are seeking a Facilities Process Engineer to support facilities and CAPEX projects, specifically involving 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, Monday to Friday, with availability for weekends and overtime as needed during testing phases.
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
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
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What This Job Offers
Job Type
Full-time
Career Level
Senior
