Engineer

FITS LLC; Añasco (PR); On-site; USD 55,000 - 75,000; Full time

Job summary

FITS LLC in Puerto Rico seeks a Validation professional to join our engineering and manufacturing services team. You will develop, write, and maintain validation protocols and ensure FDA-compliant execution across manufacturing operations.

The role requires a Bachelor's in Engineering, bilingual English/Spanish, and experience with SOP development, validation documentation, GMP and GDP, with flexibility to adapt to business needs.

Qualifications

• Bachelor’s degree in engineering with exposure to validation activities in pharma or medical devices.
• Bilingual in Spanish and English with good communication.
• Shift: Administrative and flexible per business needs.
• Experience in SOP development, validation documentation, GMP & GDP.

Responsibilities

• Write, execute and maintain validation protocols.
• Ensure timely, thorough and FDA-compliant execution of protocols.
• Integrate new and existing protocols into manufacturing processes.
• Ensure documentation is thorough and entered into the quality system.
• Investigate product/batch deviations related to validation testing.
• Document investigations and communicate findings to minimize recurrence.
• Develop and implement process strategies and maintain process documents.
• Support day-to-day process operations.

Skills

Bilingual Spanish & English

SOP Development

Validation Documentation

GMP & GDP

Shift flexibility

Exposure to validation activities

Education

Bachelor's Degree in Engineering

Job description

For Validation services in the Engineering & Manufacturing areas.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor's Degree in Engineering andprevious exposure to validation quality activities within the Pharmaceutical or Medical Devices industry.
• Bilingual, Spanish and English (good communication)
• Shift: Administrative & according to business needs
• Experience in:
  • SOP Development
  • Validation Documentation
  • GMP & GDP

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)

• Write, execute and maintain on a timely basis Validation protocols.
• Ensure timely, thorough and complete execution of all protocols, meeting FDA requirements.
• Ensure that all new and existing protocols are effectively integrated into manufacturing processes.
• Ensure documentation is thorough, accurate and entered on a timely basis into the quality system.
• Ensures complete and thorough investigation of all product failures, batch failures and deviations associated with validation sampling and testing.
• Develops documentation of investigations and communicates findings to ensure chance of recurrence is significantly minimized and resolution satisfies validation requirements.
• Responsible for developing and implementing process strategies, optimizing current processes, and maintaining process documents.
• Support the day to day process operations.

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?