Validation Engineer

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

Job summary

FITS LLC in Puerto Rico seeks a Validation professional to support validation protocols and reports across Engineering and Manufacturing. The role emphasizes collaboration with internal teams and external suppliers, ensuring compliance with GMP and GDP standards.

You will contribute to change controls, qualification activities, and implementation readiness, while leveraging statistical tools like Minitab or JMP to analyze data and drive quality outcomes.

Qualifications

• Bachelor's Degree in Engineering and exposure to validation activities in Pharma/Med Devices.
• Bilingual in Spanish and English with good communication.
• Shift: Administrative & according to business needs.
• Experience with protocol development, execution, investigations and technical documentation.

Responsibilities

• Development and execution support of validation protocols and reports.
• Change control support (CRs, TRs, VPs, protocol execution, evidence compilation, and closure activities).
• Qualification and operational readiness activities across systems, processes, and infrastructure.
• Cross-functional coordination with Engineering, Quality, Operations, Planning, Supply Chain, and external suppliers.
• Support for SOP updates, training, UAT activities, implementation readiness, and post-implementation support.
• Technical support for supplier qualification and validation activities.

Skills

Bilingual Spanish/English

Statistical tools

GMP GDP knowledge

Validation protocols

Supplier collaboration

Education

Engineering degree

Tools

Minitab/JMP

Job description

For Validation services in the Engineering & Manufacturing areas.

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor's Degree in Engineering and previous 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:
  • Protocol development, execution, investigations, and technical documentation.
  • Minitab, JMP, or similar statistical analysis tools.
  • EO/EtO sterilization processes and validation activities (preferred)
  • Working with external suppliers and supplier qualification projects (preferred)
  • 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)

• Development and execution support of validation protocols and reports.
• Change control support (CRs, TRs, VPs, protocol execution, evidence compilation, and closure activities).
• Qualification and operational readiness activities across systems, processes, and infrastructure.
• Cross-functional coordination with Engineering, Quality, Operations, Planning, Supply Chain, and external suppliers.
• Support for SOP updates, training, UAT activities, implementation readiness, and post-implementation support.
• Technical support for supplier qualification and validation activities.

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?