Senior Quality Engineer, GMP & FUME Lead (24/7)

FITS LLC; Carolina (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

FITS LLC is seeking a Senior Quality Engineering Specialist for QA Engineering (FUME: Facilities, Utilities, Maintenance & Engineering) in the Pharma/Biologics space. You will lead technical QA efforts, review qualification docs, and drive CAPA/RCA activities while ensuring GDP and data integrity.

Requires 5+ years in GMP environments, Spanish/English fluency, and a readiness to support a 24/7 operation with irregular hours. Join a service-focused team on island-wide projects in the US.

Qualifications

• Bachelor’s degree in Engineering or related field and 5+ years in Quality Engineering in GMP pharma or biologics environments.
• Bilingual Spanish and English (verbal/written).
• Willingness to support a 24/7 operation with irregular hours, shifts, weekends, and holidays.
• Experience with GMP pharma/biologics facilities, utilities, maintenance, and engineering systems.

Responsibilities

• Serve as a senior technical resource on projects involving facilities, utilities, maintenance systems, and manufacturing processes.
• Review qualification and commissioning documentation to ensure GMP-ready deliverables.
• Monitor utilities performance and trend against specifications and regulatory requirements.
• Escalate excursions and support technical assessments for QA review.
• Execute maintenance, qualification, and quality-related activities; support qualification strategy.
• Draft and maintain GDP-compliant documentation and support data integrity and regulatory readiness.

Skills

Quality Engineering

GMP

RCA

CAPA

FMEA

GDP

Data integrity

Regulatory compliance

Inspection readiness

CI initiatives

Education

Bachelor's degree in Engineering

Tools

TrackWise

Veeva

QMS

Kneat

Microsoft Office

Job description

FITS LLC is seeking a Senior Quality Engineering Specialist for QA Engineering (FUME: Facilities, Utilities, Maintenance & Engineering) in the Pharma/Biologics space. You will lead technical QA efforts, review qualification docs, and drive CAPA/RCA activities while ensuring GDP and data integrity.

Requires 5+ years in GMP environments, Spanish/English fluency, and a readiness to support a 24/7 operation with irregular hours. Join a service-focused team on island-wide projects in the US.