Compliance Engineer

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.

• →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.

• 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).

• 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.