GMP Compliance Engineer — Quality Systems & Projects

Pinnaql, Inc.; Gurabo (PR); Sur place; USD 60 000 - 85 000; Plein temps

Résumé du poste

Validation & Engineering Group, Inc. seeks a Compliance Engineer to support capital projects within regulated pharma/biotech environments. You will assist investigations, CAPA, change management, and GMP documentation, coordinating with Engineering, Operations, Quality, and Validation teams.

This on-site role in the eastern region of Puerto Rico requires strong organizational skills, technical writing, and collaboration across cross-functional teams in highly regulated settings.

Qualifications

• Bachelor’s degree in Engineering, Science, Business Administration, or related technical field preferred.
• Minimum of 2 years of experience supporting compliance, quality systems, investigations, CAPA, change management, validation, or GMP documentation activities.
• Familiarity with GMP documentation practices and regulated documentation requirements.
• Experience in regulated environments (pharma/biotech/medical device) is preferred.
• Experience with Kneat, TrackWise, Veeva, or similar platforms is preferred.
• Excellent written and verbal communication in English and Spanish.

Responsabilités

• Support investigations, CAPA activities, and quality system documentation for projects.
• Coordinate change controls, CAPAs, training activities, and compliance metrics.
• Review and route GMP documentation; ensure quality system coordination.
• Assist onboarding, forms, access requests, and related compliance support.
• Track and organize quality records, project docs, and deliverables.
• Participate in meetings and communicate compliance status, risks, and actions.
• Support continuous improvement of quality systems and regulatory processes.
• Ensure activities align with GMP requirements, site procedures, and project expectations.

Connaissances

GMP compliance

Quality systems

Regulatory documentation

Cross-functional collaboration

Technical writing

Bilingual English/Spanish

Investigations & CAPA

Attention to detail

Formation

Bachelor’s degree in Engineering, Science, or related field

Outils

Kneat

TrackWise

Veeva

Bluebeam

Description du poste

Validation & Engineering Group, Inc. seeks a Compliance Engineer to support capital projects within regulated pharma/biotech environments. You will assist investigations, CAPA, change management, and GMP documentation, coordinating with Engineering, Operations, Quality, and Validation teams.

This on-site role in the eastern region of Puerto Rico requires strong organizational skills, technical writing, and collaboration across cross-functional teams in highly regulated settings.