Engineer

FITS LLC; Humacao (PR); On-site; USD 50,000 - 80,000; Full time

Job summary

FITS is seeking a detail-oriented professional to support Test Method Validation (TMV) activities, coordinate Change Controls, and maintain technical documentation within a regulated environment in Puerto Rico. You will collaborate with Quality, Engineering, Manufacturing, and Laboratory teams, ensuring compliant processes and quality records.

Fluency in Spanish and English is required, and you will play a key role in cross-functional communication, supporting continuous improvement and

Qualifications

• Bachelor's Degree in Engineering; regulated industry experience.
• Bilingual Spanish and English with good communication.
• Shift: Administrative & according to business needs.
• Experience in TMV activities, change control, and documentation.
• Compliance with quality systems and regulatory requirements.
• Cross-functional collaboration in regulated environments.

Responsibilities

• Support Test Method Validation (TMV) activities, including protocol execution and documentation.
• Assist in the coordination, tracking, and implementation of Change Controls.
• Prepare, review, and maintain technical documentation, reports, and quality records.
• Collaborate with Quality, Engineering, Manufacturing, and Laboratory personnel to support validated processes.
• Ensure compliance with applicable quality and regulatory requirements.
• Support investigations, assessments, and actions associated with process, equipment, or method changes.
• Assist with continuous improvement initiatives and engineering projects as assigned.

Skills

TMV activities

Change Control

Documentation & records

Quality compliance

Cross-functional collaboration

Bilingual Spanish/English

Education

Bachelor's degree in Engineering

Job description

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor's Degree in Engineering and previous experience within regulated industries.
• Bilingual, Spanish and English (good communication)
• Shift: Administrative & according to business needs
• Experience in:
  • Test Method Validation (TMV) activities and supporting documentation.
  • Change Control processes, assessments, and implementation.
  • Technical documentation, procedures, protocols, and reports.
  • Compliance with quality systems and regulatory requirements.
  • Cross-functional collaboration within regulated environments.

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)

• Support Test Method Validation (TMV) activities, including protocol execution and documentation.
• Assist in the coordination, tracking, and implementation of Change Controls.
• Prepare, review, and maintain technical documentation, reports, and quality records.
• Collaborate with Quality, Engineering, Manufacturing, and Laboratory personnel to support validated processes.
• Ensure compliance with applicable quality and regulatory requirements.
• Support investigations, assessments, and actions associated with process, equipment, or method changes.
• Assist with continuous improvement initiatives and engineering projects as assigned.

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?