Senior Quality Engineer - GMP Pharma, 24/7, Bilingual

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

Job summary

FITS, LLC is seeking a Senior Quality Engineering Specialist to lead QA engineering activities within GMP facilities, utilities, maintenance, and engineering systems.

The role requires supporting a 24/7 operation, reviewing qualification documentation, and driving continuous improvement through RCA, CAPA, and risk management. You will collaborate with multiple teams to ensure GMP compliance and inspection readiness.

Qualifications

• Bachelor’s degree in Engineering or related discipline and at least five (5) years of experience in Quality Engineering within GMP pharmaceutical or biologics manufacturing environments, preferably supporting API operations.
• Bilingual: Spanish and English (verbal/written).
• Availability to support a 24/7 operation, including irregular hours, shift rotations, weekends, holidays, and emergencies.
• Experience in GMP pharmaceutical or biologics manufacturing environments, including Facilities, Utilities, Maintenance, and Engineering (FUME) systems.
• Commissioning, qualification, validation, and engineering documentation processes.
• Investigations, root cause analysis (RCA), CAPA, change control, and risk management (FMEA preferred).
• GDP, data integrity, regulatory compliance, and inspection readiness activities.
• Microsoft Office and quality systems such as TrackWise, Veeva, QMS, Kneat; experience supporting continuous improvement.

Responsibilities

• Serve as a senior technical resource from Quality Engineering on projects involving facilities, utilities, maintenance systems, and manufacturing processes.
• Review qualification and commissioning documentation to ensure GMP-ready deliverables.
• Monitor and trend qualified utilities performance against specifications and regulatory requirements.
• Escalate utility excursions and support technical assessments for Quality Engineering review.
• Execute maintenance, engineering, qualification, and quality-related activities.
• Support qualification strategy development and implementation activities.
• Draft and progress investigations, conduct RCA for events and support CAPA implementation.
• Facilitate problem-solving, risk assessments, FMEA, and quality risk-management initiatives.
• Draft, route, and support change controls across affected areas.
• Prepare, review, and maintain audit-defensible technical documentation per GDP and data integrity.
• Communicate significant quality issues to Quality Engineering and Quality Management teams.
• Support inspection readiness activities including regulatory inspections and GMP audits.
• Participate in self-inspection programs and remediation activities as required.
• Use statistical analysis and data to drive continuous improvement.
• Collaborate with Engineering, Maintenance, Operations, Validation, and Quality teams to ensure compliant execution.

Skills

Bilingual: Spanish and English

Education

Bachelor’s degree in Engineering or related discipline

Tools

TrackWise

Veeva

QMS

Kneat

Job description

FITS, LLC is seeking a Senior Quality Engineering Specialist to lead QA engineering activities within GMP facilities, utilities, maintenance, and engineering systems.

The role requires supporting a 24/7 operation, reviewing qualification documentation, and driving continuous improvement through RCA, CAPA, and risk management. You will collaborate with multiple teams to ensure GMP compliance and inspection readiness.