Quality Engineer

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

Job summary

FITS provides specialized QA Engineering services in the FUME area, seeking a Senior Quality Engineering Specialist with 5+ years in automated GMP operations. Requires an Engineering degree and bilingual Spanish/English, with flexibility for 24/7 coverage and strong documentation practices.

Responsibilities include supporting assets, utilities, maintenance and qualification activities, investigations, RCA, CAPA and change control, along with GDP and data integrity compliance.

Qualifications

• Bachelor's degree in Engineering and 5+ years in automated GMP operations.
• Bilingual Spanish and English (verbal/written).
• Willingness to support 24/7 operation, including irregular hours, shift rotations, weekends, holidays and emergencies.
• Experience in GMP pharma/biologics manufacturing, including FUME systems, quality systems and documentation processes.
• Familiarity with GDP, data integrity, regulatory compliance and inspection readiness.

Responsibilities

• Serve as a technical resource for assets (equipment/facilities), utilities and processes to support compliant deliverables.
• Support monitoring of qualified utilities performance against internal and external quality requirements.
• Assist maintenance, engineering and qualification activities and strategies.
• Contribute to event investigations and Root Cause Analysis led by QA Engineers.
• Support problem solving and risk management activities.
• Assist in change controls development and implementation.
• Ensure documentation meets GDP and data integrity requirements.
• Notify QA Engineer or Quality management of significant quality-related issues.

Skills

Bilingual: Spanish/English

Education

Bachelor's degree in Engineering

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?