Compliance Engineer: GMP Quality Systems & CAPA Specialist

Pinnaql, Inc.; Juncos (PR); On-site; USD 60,000 - 85,000; Full time

Job summary

Validation & Engineering Group, Inc. seeks a Compliance Engineer to support regulated pharmaceutical and biotech initiatives.

You will assist with quality systems, CAPA, change controls, validation activities, and GMP documentation within engineering projects. This on-site role in Puerto Rico requires bilingual English/Spanish communication, strong attention to detail, and collaboration across Engineering, Operations, Quality, Validation, and project teams in highly regulated environments.

Qualifications

• Bachelor’s degree in Engineering, Science, Business Administration, or related technical field.
• Minimum of 2 years of experience supporting compliance, quality systems, investigations, CAPA, change management, validation, or GMP documentation activities within pharmaceutical, biotechnology, medical device, or other FDA-regulated industries.
• Familiarity with GMP documentation practices, quality systems, investigations, CAPA processes, change controls, and regulated documentation requirements.
• Experience supporting engineering projects, manufacturing operations, commissioning and qualification activities, or regulated operational environments is preferred.
• Familiarity with systems such as Kneat, TrackWise, Veeva, Bluebeam, or similar quality and documentation management platforms is preferred.
• Excellent verbal and written communication skills in both English and Spanish, including technical writing, documentation review, and communication with cross-functional teams.
• Strong organizational, analytical, and problem-solving skills with attention to detail and the ability to manage multiple priorities simultaneously.

Responsibilities

• Support investigations, CAPA activities, and quality system documentation associated with project execution and engineering operations.
• Support tracking and follow-up of change controls, CAPAs, training activities, and compliance-related metrics.
• Support document reviews, approvals, document routing, and quality system coordination activities.
• Assist with onboarding coordination activities, forms, access requests, and related compliance documentation support.
• Support tracking and organization of quality records, project documentation, and compliance-related deliverables.
• Participate in project meetings and support communication of compliance activities, documentation status, risks, and action items.
• Support continuous improvement initiatives related to quality systems, compliance processes, documentation practices, and operational readiness activities.
• Ensure compliance activities are performed in alignment with applicable GMP requirements, site procedures, and project expectations.

Skills

Bilingual English/Spanish

Cross-functional collaboration

Attention to detail

Education

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

Tools

Kneat

TrackWise

Veeva

Bluebeam

Job description

Validation & Engineering Group, Inc. seeks a Compliance Engineer to support regulated pharmaceutical and biotech initiatives.

You will assist with quality systems, CAPA, change controls, validation activities, and GMP documentation within engineering projects. This on-site role in Puerto Rico requires bilingual English/Spanish communication, strong attention to detail, and collaboration across Engineering, Operations, Quality, Validation, and project teams in highly regulated environments.