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 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

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!