Quality & Compliance Engineer – On-site in Puerto Rico

Pinnaql, Inc.; Juncos (PR); On-site; USD 70,000 - 100,000; Full time

Job summary

Validation & Engineering Group, Inc. in Puerto Rico is seeking a Compliance Engineer to support capital projects and regulatory initiatives in pharma and biotech environments.

You will contribute to quality systems, investigations, CAPA, change controls, and GMP documentation review across engineering and project teams. The ideal candidate has a bachelor's degree in a technical field, 2+ years of FDA-regulated experience, and fluency in English and Spanish.

Qualifications

• Bachelor’s degree in Engineering, Science, Business Admin, or related field.
• Minimum 2 years of experience in compliance, quality systems, CAPA, change management, validation, or GMP documentation in FDA-regulated industries.
• Familiarity with GMP documentation, quality systems, investigations, CAPA processes, change controls; regulated documentation requirements.
• Experience supporting engineering projects or regulated operations is preferred.
• Experience with Kneat, TrackWise, Veeva, or Bluebeam is preferred.

Responsibilities

• Support investigations, CAPA activities, and quality system documentation.
• Assist tracking and follow-up of change controls, CAPAs, training activities, and compliance metrics.
• Review, approve, document routing, and coordinate quality system activities.
• Assist onboarding coordination activities, forms, access requests, and related compliance documentation.
• Track and organize quality records, project documentation, and deliverables.
• Participate in project meetings and communicate compliance status, risks, and actions.
• Support continuous improvement initiatives related to quality systems and documentation practices.
• Ensure compliance activities align with GMP requirements, site procedures, and project expectations.

Skills

Bilingual English/Spanish

Regulatory compliance

Quality systems

Documentation

Cross-functional collaboration

Education

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

Tools

Kneat

TrackWise

Veeva

Bluebeam

Job description

Validation & Engineering Group, Inc. in Puerto Rico is seeking a Compliance Engineer to support capital projects and regulatory initiatives in pharma and biotech environments.

You will contribute to quality systems, investigations, CAPA, change controls, and GMP documentation review across engineering and project teams. The ideal candidate has a bachelor's degree in a technical field, 2+ years of FDA-regulated experience, and fluency in English and Spanish.