Compliance Engineer

Pinnaql, Inc.; Juncos (PR); Presencial; USD 60.000 - 85.000; Jornada completa

Descripción de la vacante

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.

Formación

• 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.

Responsabilidades

• 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.

Conocimientos

Bilingual English/Spanish

Cross-functional collaboration

Attention to detail

Educación

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

Herramientas

Kneat

TrackWise

Veeva

Bluebeam

Descripción del empleo

Validation & Engineering Group, Inc. (V&EG) a Pinnaql company is a leading services supplier who provides solutions for the Pharmaceutical, Biotechnology, Chemical, Food, and Medical Devices industries in the following areas: Laboratory, Compliance, Computer, Engineering, Project Management, Validation, and other services.

We are seeking a talented, dedicated individual committed to work under the highest ethics standards for the following position:

• Compliance Engineer

Position Summary

The Compliance Engineer will support capital projects and technical initiatives within regulated pharmaceutical and biotechnology manufacturing environments by supporting quality and compliance activities associated with project execution, engineering operations, and regulated systems.

This role is responsible for supporting investigations, CAPA activities, change management coordination, GMP documentation review, compliance tracking, and quality system support activities associated with engineering and project operations.

The role requires strong organizational skills, attention to detail, technical writing capabilities, and cross-functional collaboration with Engineering, Operations, Quality, Validation, and project teams within highly regulated environments.

Key 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.

Qualifications & Experience

• 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.
• 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.

Additional Requirements

• 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.

The above statements describe the general nature and level of work performed and do not represent an exhaustive list of responsibilities.

At Validation & Engineering Group, people always come first. We believe that when you're empowered to do your best work, bold ideas thrive and real progress happens. This isn't just a job - it's an opportunity to make a meaningful difference by shaping the future of healthcare and technology alongside a purpose-driven, supportive team.

Excited to build something meaningful together? We look forward to hearing from you.

Validation & Engineering Group is an equal opportunity employer. All applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran status, or disability status.