Associate Engineer - Quality & Validation (Pharma/Med)

FITS LLC; Caguas (PR); On-site; USD 60,000 - 90,000; Full time

Job summary

FITS LLC in Puerto Rico is seeking a Quality Engineer to support engineering services in the pharmaceutical and medical device industry.

The role requires a Bachelor's in Engineering, bilingual English/Spanish, and hands-on experience with manufacturing processes, documentation, validation protocols, investigations, and troubleshooting. You will work second shift (1pm–10pm) and collaborate across functions to ensure product quality and regulatory compliance.

Qualifications

• Bachelor's degree in Engineering with experience in the Pharmaceutical or Medical Device industry.
• Bilingual (English & Spanish).
• Project management skills.
• Shift: Second (1pm to 10pm) and according to business needs.
• Experience in Manufacturing Process, Documentation, Validation Protocols, Investigations, Troubleshooting.

Responsibilities

• Develops product quality plans, documents and systems by providing input to product specifications, quality specifications, quality plans, risk analyses.
• Implements changes through change management system and provides quality engineering impact assessment for changes implemented by other functional areas.
• Write and approve protocols and reports with minimal management oversight to support engineering studies and validations.
• Can generate and approve qualification and validation protocols and reports with minimal oversight.
• Monitor progress and performance against the project plan.
• Anticipates potential situations that may impact projects timeline and resolves them before they become an issue.
• Is the technical liaison with other cross functional areas with other sites.

Skills

Bilingual English/Spanish

Project management

Quality engineering

Troubleshooting

Process validation

Documentation

Education

Bachelor's Degree in Engineering

Job description

FITS LLC in Puerto Rico is seeking a Quality Engineer to support engineering services in the pharmaceutical and medical device industry.

The role requires a Bachelor's in Engineering, bilingual English/Spanish, and hands-on experience with manufacturing processes, documentation, validation protocols, investigations, and troubleshooting. You will work second shift (1pm–10pm) and collaborate across functions to ensure product quality and regulatory compliance.