Quality Engineer: Drive Validation & Compliance in Pharma

FITS LLC; Añasco (PR); On-site; USD 60,000 - 80,000; Full time

Job summary

FITS LLC, a service provider in the island and the US, seeks a Quality Engineering professional to support new products and processes in the Pharmaceutical and Medical Devices sectors.

The role focuses on validating and certifying processes, test methods, equipment, and utilities, while ensuring GMP and GDP compliance and robust quality documentation. You will collaborate across functions to maintain product quality and regulatory alignment.

Qualifications

• Bachelor's degree in Engineering with 3+ years in Quality within pharma/medical devices.
• Bilingual in Spanish and English with good communication.
• Shift: Administrative role per business needs.
• Experience in Validation Life Cycle, Change Control, Documentation, GMP & GDP regulations.

Responsibilities

• Support the implementation of effective quality engineering processes for new products, processes, and technology.
• Provides support to the validation and certification of process, test methods, equipment, software, utilities, and facilities as required.
• Generates test protocols, monitors testing, issues qualification test reports and approves qualifications plans/reports.
• Provides support on activities, documents and records requiring Quality Engineering review and/or approval as deemed necessary.
• Alerts the organization to issues in time to resolve potential adverse effects on the customer, company image, or reputation of the business.
• Works with multi-functional teams to establish project plans and ensure uninterrupted support to new projects balanced with manufacturing operations.
• Develops standard operating procedures, specifications, and provides technical transfer and validation support.
• Utilizes appropriate risk management tools to prevent unanticipated failure modes and improve capability of processes.

Skills

Bilingual Spanish English

Education

Bachelor's Degree in Engineering

Job description

FITS LLC, a service provider in the island and the US, seeks a Quality Engineering professional to support new products and processes in the Pharmaceutical and Medical Devices sectors.

The role focuses on validating and certifying processes, test methods, equipment, and utilities, while ensuring GMP and GDP compliance and robust quality documentation. You will collaborate across functions to maintain product quality and regulatory alignment.