Compliance Engineer

Inteldot; Gurabo (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

Inteldot is seeking a Compliance Engineer in Gurabo to support GMP compliance activities in capital project execution within a regulated manufacturing environment. This role involves managing investigations, CAPAs, documentation control, and compliance metrics.

The ideal candidate should have a Bachelor’s degree in engineering, with at least 3 years of experience in the pharmaceutical industry, particularly in capital project management. Strong knowledge of GMP regulations is essential. The position requires bilingual proficiency in Spanish and English and offers full-time onsite work.

Qualifications

• 3+ years of experience managing capital projects in the pharmaceutical industry.
• Strong understanding of GMP regulations and quality systems.
• Experience managing CAPAs, investigations, and change control processes.

Responsibilities

• Manage investigations and CAPAs arising from Project Execution.
• Monitor GMP compliance metrics, including training and CAPA effectiveness.
• Conduct GMP reviews of project and site documentation.

Skills

GMP regulations

Project management

Documentation review

Bilingual (Spanish and English)

Education

Bachelor’s degree in engineering or related technical discipline

Tools

TrackWise

Kneat

Job description

Inteldot has over 15 years in the life sciences industry, with operations across Puerto Rico, the United States, Europe, and Japan. This is a great opportunity for one of our leading clients in Puerto Rico.

Employment type: Full time and onsite role

Role Summary

The Compliance Engineer supports GMP compliance activities within capital project execution and site engineering functions in a regulated pharmaceutical manufacturing environment. This role ensures proper management of investigations, CAPAs, documentation control, and compliance metrics while supporting adherence to GMP standards, regulatory requirements, and internal quality systems.

Key Responsibilities

• Manage investigations and Corrective and Preventive Actions (CAPAs) arising from Project Execution and Site Engineering teams.
• Monitor GMP compliance metrics, including training completion, change control on-time closure, and CAPA effectiveness and timeliness.
• Conduct GMP reviews of project and site documentation to ensure compliance with regulatory and internal standards.
• Revise and maintain controlled documents using systems such as TrackWise (TV) and Kneat.
• Support document lifecycle management, ensuring accuracy, completeness, and compliance with GMP requirements.
• Facilitate new hire onboarding processes, including generation of required forms and IAM ticket submission and tracking.
• Collaborate with engineering, quality, and operations teams to ensure timely resolution of compliance-related issues.
• Support continuous improvement initiatives related to compliance processes and documentation practices.

Requirements & Qualifications

• Bachelor’s degree in engineering or related technical discipline.
• Minimum 3 years of experience managing capital projects in the pharmaceutical industry.
• Experience with manufacturing and packaging processes and equipment in synthetic and/or biotherapeutic environments.
• Strong understanding of GMP regulations and quality systems.
• Experience managing CAPAs, investigations, and change control processes.
• Familiarity with electronic quality systems such as TrackWise (TV), Kneat, or equivalent platforms.
• Strong documentation review, analytical, and problem-solving skills.
• Bilingual (Spanish and English).

Preferred Qualifications

• Experience supporting pharmaceutical manufacturing or site engineering compliance activities.
• Knowledge of data integrity and audit readiness expectations.
• Familiarity with onboarding processes, IAM systems, and controlled document workflows.
• Experience working in cross-functional GMP-regulated environments.