Sr. Quality Engineer

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

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 or related discipline and at least five (5) years of experience in Quality Engineering within GMP pharmaceutical or biologics manufacturing environments, preferably supporting API (bulk drug substance) 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.
  • 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.
  • Microsoft Office and quality systems such as TrackWise, Veeva, QMS, Kneat, or similar platforms; experience supporting continuous improvement initiatives is preferred.

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 senior technical resource from the Quality Engineering perspective on projects and team initiatives involving facilities, equipment, utilities, maintenance systems, and manufacturing processes.
• Review qualification and commissioning documentation to ensure compliant, GMP-ready deliverables.
• Monitor and trend qualified utilities performance against internal specifications and applicable regulatory requirements.
• Escalate utility excursions and support preparation of technical assessments for Quality Engineering review.
• Execute assigned maintenance, engineering, qualification, and quality-related activities.
• Support qualification strategy development and implementation activities.
• Author and progress investigations, conducting Root Cause Analysis (RCA) for assigned events and supporting CAPA implementation activities.
• Facilitate problem-solving efforts and participate in risk assessments, FMEA activities, and quality risk-management initiatives.
• Draft, route, coordinate, and support the implementation of change controls across impacted functional areas.
• Prepare, review, and maintain audit-defensible technical documentation that complies with Good Documentation Practices (GDP) and data-integrity requirements.
• Communicate significant quality-related issues promptly to Quality Engineering and Quality Management teams.
• Support inspection readiness efforts including regulatory inspections, pre-approval inspections (PAI), biologics license application (BLA) inspections, and routine GMP audits.
• Participate in self-inspection programs and support remediation activities as required.
• Utilize statistical analysis and process data to identify variability and drive continuous improvement initiatives.
• Collaborate with Engineering, Maintenance, Operations, Validation, and Quality teams to ensure compliant execution of activities and timely project completion.
• Operate with minimal supervision while maintaining compliance within assigned authority levels and quality requirements.

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?