Compliance Engineer

Summary

Validation & Engineering Group, a Pinnaql company, is a leading services supplier in the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries. They are seeking a Compliance Engineer to support capital projects and technical initiatives within regulated environments, focusing on quality and compliance activities associated with engineering operations and project execution.

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

• 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 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
• 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
• Ability to work on-site in the eastern region of Puerto Rico
• Must be eligible to complete client-required onboarding, training, and site access requirements
• Ability to work effectively within fast-paced and highly regulated environments
• Experience supporting engineering projects, manufacturing operations, commissioning and qualification activities, or regulated operational environments
• Familiarity with systems such as Kneat, TrackWise, Veeva, Bluebeam, or similar quality and documentation management platforms

Qualifications

Must Haves

• 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 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
• 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
• Ability to work on-site in the eastern region of Puerto Rico
• Must be eligible to complete client-required onboarding, training, and site access requirements
• Ability to work effectively within fast-paced and highly regulated environments

Nice to Haves

• Experience supporting engineering projects, manufacturing operations, commissioning and qualification activities, or regulated operational environments
• Familiarity with systems such as Kneat, TrackWise, Veeva, Bluebeam, or similar quality and documentation management platforms