Engineer

FITS, LLC; Añasco (PR); On-site; USD 50,000 - 75,000; Full time

Job summary

FITS, LLC is seeking a Validation professional to support engineering and manufacturing validation activities in Puerto Rico. The candidate should have a Bachelor’s in Engineering and exposure to pharmaceutical or medical device validation projects, with bilingual Spanish/English communication.

The role involves writing and executing validation protocols, ensuring FDA-aligned documentation, and contributing to process improvements while supporting day-to-day operations in a dynamic,

Qualifications

• Bachelor's Degree in Engineering with exposure to validation activities in Pharma or Medical Devices.
• Bilingual in Spanish and English with good communication.
• Experience in SOP Development, Validation Documentation, GMP & GDP.

Responsibilities

• Write, execute and maintain validation protocols.
• Ensure timely, thorough execution of protocols meeting FDA requirements.
• Integrate protocols into manufacturing processes and maintain documentation in the quality system.
• Investigate product and batch deviations related to validation sampling and testing; document investigations.
• Develop and implement process strategies, optimize processes, and maintain process documents.
• Support day-to-day process operations.

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!