Quality Engineer

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

For Senior Quality Engineering Specialist services in the Quality Assurance / QA Engineering (FUME: Facilities, Utilities, Maintenance & Engineering) area.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor’s degree in Engineering (Chemical, Biotechnical, Biomedical, or Mechanical)and at least five (5) years of experience in automated bulk pharmaceutical GMP operations (Production, Engineering, QA, or Technical Services), with understanding of facilities, utilities, maintenance, commissioning & qualification, and quality systems.
• 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.
  • Quality Systems and computer platforms (e.g., Microsoft Office, TrackWise, Veeva QDocs, QMS, Kneat, GMARS).
  • 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.

The Personality Part:

• Our Next Piece is someone who treats everyone they meet like family, especially our resources, clients, and team members. In other words, being a customer service pro is one your (many) talents. Being the Piece means you're full of bright ideas and eager to innovate, always bringing top-quality results to the table. Are you ready to take on this new challenge?

AS A PIECE OF FITS, YOU WILL:

(The day-to-day on the job)

• Serve as a technical resource for initiatives and projects related to assets (equipment/facilities), 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 Good Documentation Practices (GDP) and data integrity requirements.
• Notify the assigned QA Engineer or Quality management of significant quality-related issues in a timely manner.

WHO WE ARE:

We are a Service Provider companydifferent from the rest. We pride ourselves in how we treat the most important piece of our company's puzzle: you! We integrate Engineering, Construction, Maintenance, Utilities and Specialized Technical services across the Island (and in the US as well!). Our company is flexible, family-oriented and focused on our resources' well-being, while providing our Pharmaceutical, Medical Device and Manufacturing industryclients with top-notch quality talent.We're FITS!

Are you the Next Piece?