Compliance Engineer - GMP & Quality Systems (Pharma)

Validation & Engineering Group, Inc.; Gurabo (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

Validation & Engineering Group, Inc. is a leading provider of validation, quality, and compliance services for highly regulated industries in Puerto Rico.

The Compliance Engineer will support capital projects, investigations, CAPAs, change management, and GMP documentation within regulated pharmaceutical and biotech environments. The role requires strong organizational and writing skills, detailed attention, and cross-functional collaboration with Engineering, Operations, Quality, Validation,

Qualifications

• Bachelor's degree in Engineering, Science, Business Admin, or related technical field preferred.
• 2+ years of experience in compliance, quality systems, investigations, CAPA, change management, validation, or GMP documentation in FDA-regulated industries.
• Familiarity with GMP documentation practices and quality systems.
• Experience supporting engineering projects, manufacturing operations, commissioning and qualification activities.

Responsibilities

• Support investigations, CAPA and quality system documentation for project execution.
• Track change controls, CAPAs, training activities, and compliance metrics.
• Review and route documents; coordinate quality system activities.
• Assist onboarding coordination, forms, access requests, and related compliance support.
• Organize quality records and project documentation; manage deliverables.
• Participate in project meetings and communicate compliance status, risks, actions.
• Contribute to continuous improvement of quality systems and operational readiness.
• Ensure activities align with GMP requirements and site procedures.

Skills

Bilingual communication

Organizational skills

Analytical skills

Education

Bachelor's degree

Tools

Kneat

TrackWise

Veeva

Bluebeam

Job description

Validation & Engineering Group, Inc. is a leading provider of validation, quality, and compliance services for highly regulated industries in Puerto Rico.

The Compliance Engineer will support capital projects, investigations, CAPAs, change management, and GMP documentation within regulated pharmaceutical and biotech environments. The role requires strong organizational and writing skills, detailed attention, and cross-functional collaboration with Engineering, Operations, Quality, Validation,