Pharma Compliance Engineer: CAPA, Change Control & QA

Pinnaql, Inc.; Humacao (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

Validation & Engineering Group, Inc. is seeking a dedicated Compliance Engineer to support capital projects and regulated manufacturing environments in Puerto Rico.

The role emphasizes investigations, CAPA, change management, GMP documentation reviews, and quality system support across Engineering, Operations, Quality, Validation, and project teams. On-site work in the eastern region of Puerto Rico is required.

Qualifications

• Bachelor’s degree in Engineering, Science, Business Administration, or related field.
• Minimum 2 years in compliance, quality systems, CAPA, change management, validation, or GMP docs.
• Familiarity with GMP docs, quality systems, investigations, CAPA, change controls.
• Experience in regulated environments (pharma/biotech/medical devices).
• Experience with Kneat, TrackWise, Veeva, Bluebeam preferred.

Responsibilities

• Support investigations, CAPA activities, and quality system docs.
• Track change controls, CAPAs, training, and compliance metrics.
• Review and route documents, coordinate quality system activities.
• Assist onboarding and access documentation.
• Organize quality records and project documentation.
• Participate in project meetings and communicate status, risks, actions.
• Support continuous improvement of quality systems and processes.
• Ensure GMP compliance with site procedures.

Skills

Communication skills

GMP knowledge

Documentation/technical writing

Problem solving

Bilingual English/Spanish

Education

Bachelor's degree in Engineering, Science, Business Administration, or related field

Tools

Kneat

TrackWise

Veeva

Bluebeam

Job description

Validation & Engineering Group, Inc. is seeking a dedicated Compliance Engineer to support capital projects and regulated manufacturing environments in Puerto Rico.

The role emphasizes investigations, CAPA, change management, GMP documentation reviews, and quality system support across Engineering, Operations, Quality, Validation, and project teams. On-site work in the eastern region of Puerto Rico is required.