Compliance Engineer - Pharmaceutical - C&Q

LEGAL PROJECT MANAGEMENT PARTNERS LLC•Caguas, PR

1d•Hybrid

About The Position

WE ARE LOOKING FOR A COMPLIANCE ENGINEER WITH EXPERIENCE SUPPORTING PHARMACEUTICAL PROJECTS AND C&Q ACTIVITIES IN REGULATED ENVIRONMENTS. IN THIS ROLE, YOU WILL WORK CLOSELY WITH ENGINEERING, QUALITY, VALIDATION, AND MANUFACTURING TEAMS TO ENSURE SYSTEMS, EQUIPMENT, AND PROCESSES MEET COMPLIANCE AND QUALITY REQUIREMENTS. THIS IS AN EXCELLENT OPPORTUNITY FOR PROFESSIONALS WHO ENJOY WORKING IN FAST-PACED PHARMACEUTICAL ENVIRONMENTS AND CONTRIBUTING TO HIGH-IMPACT PROJECTS.

Requirements

Strong knowledge of GMP regulations and pharmaceutical compliance standards.
Familiarity with Commissioning & Qualification (C&Q) methodologies and lifecycle processes.
Understanding of validation principles and documentation practices.
Knowledge of FDA regulations, GAMP, and industry guidelines.
Excellent written and verbal communication skills.
Strong analytical, organizational, and problem-solving abilities.
Ability to work independently and in cross-functional environments.
Proficiency with Microsoft Office Suite and documentation management systems
Minimum 3+ years of experience in pharmaceutical, biotechnology, or regulated manufacturing environments.
Experience supporting Commissioning & Qualification (C&Q), Validation, Compliance, or Quality Engineering activities.
Previous experience with GMP-regulated environments required.

Nice To Haves

Experience with qualification protocols (IQ/OQ/PQ), change controls, deviations, and CAPAs preferred.
Experience supporting manufacturing facilities, utilities, process equipment, or laboratory systems is a plus.

Responsibilities

Support compliance activities associated with pharmaceutical engineering and C&Q projects.
Assist in the execution and review of Commissioning, Qualification, and Validation documentation.
Develop, review, and approve protocols and reports including IQ, OQ, and PQ documentation.
Ensure activities comply with GMP, FDA, and applicable regulatory requirements.
Participate in deviation investigations, CAPAs, change controls, and risk assessments.
Collaborate with Quality Assurance, Manufacturing, Engineering, and Validation teams.
Support audits, inspections, and regulatory readiness initiatives.
Review and ensure accuracy of technical documentation and project deliverables.
Monitor project compliance metrics and maintain proper documentation practices.
Support continuous improvement initiatives and quality system enhancements.
Ensure all documentation follows data integrity and compliance standards.