Senior Quality Engineer – GMP Pharma, FUME Systems

FITS LLC; Carolina (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

FITS LLC is seeking a Senior Quality Engineering Specialist for QA Engineering (FUME: Facilities, Utilities, Maintenance & Engineering) to support GMP operations. The role requires a bachelor’s degree in engineering and at least five years in automated pharma environments, with bilingual Spanish/English capabilities.

The candidate will assist with commissioning, qualification, validation, investigations, CAPA, and change control, ensuring GDP and data integrity in regulatory-compliant

Qualifications

• Bachelor’s degree in Engineering (Chemical, Biotechnical, Biomedical, or Mechanical) and at least five (5) years of experience in automated bulk pharmaceutical GMP operations.
• Bilingual: Spanish and English (verbal/ written).
• Availability to support a 24/7 operation, including irregular hours, shift rotations, weekends, holidays, and emergency situations according to business needs.
• Experience in GMP pharmaceutical or biologics manufacturing environments, including Facilities, Utilities, Maintenance, and Engineering (FUME) systems.
• Experience with Quality Systems and computer platforms (e.g., TrackWise, Veeva QDocs, QMS, Kneat, GMARS).
• Knowledge of commissioning, qualification, validation, and engineering documentation processes.
• Investigations, Root Cause Analysis (RCA), CAPA, change control, and risk management methodologies (FMEA preferred).
• Good Documentation Practices (GDP), data integrity principles, regulatory compliance, and inspection readiness activities.

Responsibilities

• Serve as a technical resource for initiatives and projects related to assets, utilities, and processes to support compliant deliverables.
• Support monitoring of qualified utilities performance against internal and external quality requirements and regulations.
• Support execution of maintenance, engineering, and qualification activities and strategies.
• Support event investigations and participate in Root Cause Analysis led by QA Engineers.
• Support problem solving and risk management activities.
• Support change controls development and implementation.
• Ensure assigned documentation has good technical writing and complies with GDP and data integrity requirements.
• Notify the assigned QA Engineer or Quality management of significant quality-related issues in a timely manner.

Skills

Bilingual Spanish/English

GMP pharmaceutical experience

Quality systems familiarity

Documentation & GDP

Investigations & RCA / CAPA

Regulatory compliance & data integrity

Education

Bachelor’s degree in Engineering (Chemical/Biotechnical/Biomedical/Mechanical)

Tools

TrackWise

Veeva QDocs

QMS

Kneat

GMARS

Microsoft Office

Job description

FITS LLC is seeking a Senior Quality Engineering Specialist for QA Engineering (FUME: Facilities, Utilities, Maintenance & Engineering) to support GMP operations. The role requires a bachelor’s degree in engineering and at least five years in automated pharma environments, with bilingual Spanish/English capabilities.

The candidate will assist with commissioning, qualification, validation, investigations, CAPA, and change control, ensuring GDP and data integrity in regulatory-compliant