Senior QA Engineer – Facilities & Quality Systems

ProQuality Network; Puerto Rico; Híbrido; USD 90.000 - 150.000; Jornada completa

Descripción de la vacante

ProQuality Network is seeking a Senior QA Engineer to optimize site utilities and quality processes within the Facilities and Engineering organization. The role emphasizes deviations, CAPA, Change Controls, and documentation management in a regulated environment.

The candidate will support OEFM electronic forms, pest control program activities, and engineering tasks related to HVAC, cooling towers, and chilled water systems, ensuring compliance and continuous improvement across operations.

Formación

• Must have engineering degree with 8+ years hands-on experience in facilities and quality engineering.
• Experience with deviations, CAPA, Change Controls, and related quality documentation.
• Knowledge of regulatory requirements such as FDA.
• Experience supporting electronic forms and facilities-management systems.
• Strong problem-solving, organizational and analytical skills.

Responsabilidades

• Provide primary support for Quality Systems activities, including deviations, CAPAs, Change Controls, and related quality documentation.
• Investigate deviations and ensure compliance with SOPs; monitor timelines for CAPAs.
• Coordinate documentation changes; ensure regulatory alignment and internal quality standards.
• Support creation, review, routing, and tracking of OEFM electronic forms; resolve form-related questions.
• Assist pest control program management and collaboration with vendors and internal teams.
• Support Change Control processes for facilities, utilities, equipment, and critical systems.
• Evaluate and optimize preventive/predictive maintenance plans for HVAC, cooling towers, and process chilled water systems.

Conocimientos

Quality Systems

CAPA management

Change Controls

Documentation

OEFM electronic forms

Pest control programs

FDA regulations

Problem-solving

Analytical skills

Communication

Educación

Doctorate degree

Master’s degree

Bachelor’s degree

Pharmaceutical/biotech manufacturing knowledge

Industrial chilled water, cooling towers, HVAC systems

Validation & documentation processes

Deviations & CAPA management

Herramientas

OEFM electronic forms system

QMS software

Descripción del empleo

ProQuality Network is seeking a Senior QA Engineer to optimize site utilities and quality processes within the Facilities and Engineering organization. The role emphasizes deviations, CAPA, Change Controls, and documentation management in a regulated environment.

The candidate will support OEFM electronic forms, pest control program activities, and engineering tasks related to HVAC, cooling towers, and chilled water systems, ensuring compliance and continuous improvement across operations.