Validation Specialist

FITS LLC; Dorado (PR); On-site; USD 70,000 - 90,000; Full time

Job summary

FITS LLC in Dorado, Puerto Rico is seeking a qualified professional for Validation services in the Medical Devices Industry. The ideal candidate must have a Bachelor's in Life Sciences and five years of experience in Validation activities, alongside strong skills in data analysis tools and bilingual proficiency in English and Spanish. Responsibilities include utilizing automation tools for documentation extraction, validating data accuracy, and executing assessments across OQ, PQ, TMV, and IPM. Our company values flexibility and a family-oriented atmosphere.

Qualifications

• Five (5) years of experience in Validation activities within the Medical Devices Industry.
• Experience in regulated environments (FDA, ISO, GMP).
• Great attitude and strong desire to learn new skills.

Responsibilities

• Utilize automated tools to extract and filter validation documentation.
• Review and validate extracted data to ensure accuracy and completeness.
• Execute detailed assessments across OQ, PQ, TMV, and IPM.

Skills

Validation activities

Data analysis tools

Bilingual: English and Spanish

Education

Bachelor's in Life Sciences

Tools

Windchill

Excel

Job description

For Validation services

WHAT MAKES YOU A FIT

The Technical Part:

• Bachelor's in Life Sciences with five (5) years of experience in Validation activities within the Medical Devices Industry.
• Bilingual: English and Spanish
• Soft Skills: Great attitude and strong desire to learn new skills.
• Shift: Administrative, and according to business needs.
• Experience in:
  • Validation (OQ/PQ/TMV/IPM)
  • Quality Engineering or Manufacturing Engineering
  • Validation lifecycle and documentation
  • Regulated environments (FDA, ISO, GMP)
  • Data analysis tools
  • Document management systems

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 of 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)

• Utilize automated tools to extract and filter validation documentation (e.g., Windchill → Excel trackers)
• Review and validate extracted data to ensure accuracy, completeness, and site alignment
• Execute detailed assessments across: OQ (Operational Qualification), PQ (Performance Qualification), TMV (Test Method Validation) and IPM (In-Process Monitoring).
• Apply technical judgment to: Confirm applicability of validation documentation and identify discrepancies such as missing, conflicting, or outdated records.
• Ensure alignment with: Current procedures, global validation standards and Remediation expectations and timelines.
• Validate that extracted data accurately reflects site practices and documentation
• Cross-check validation records against MVPs (Master Validation Plans), PRAs (Product Risk Assessments) and supporting validation documentation.
• Identify and quantify products requiring remediation across OQ, PQ, TMV, and IPM.
• Highlight high-risk, complex, or ambiguous scenarios requiring deeper analysis.
• Proactively identify: Data gaps, inconsistencies and tool limitations.
• Escalate risks, uncertainties, or blockers to the core team in a timely manner.
• Provide clear documentation of findings and recommended actions.

WHO WE ARE

We are a Service Provider company different 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 industry clients with top-notch quality talent. We\'re FITS!

Are you the next piece?