Validation Engineer

For Validation services 

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor's in Engineering with five (5) years of experience in Validation activities within the Medial 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

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to: Confirm applicability of validation documentation and identify discrepancies such as missing, conflicting, or outdated records.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?