Validation Specialist

FITS LLC; Dorado (PR); On-site; USD 90,000 - 120,000; Full time

Job summary

FITS LLC seeks a Bachelor’s in Engineering professional with 5 years of Validation experience in the Medical Devices industry. The role requires bilingual English/Spanish, a strong quality mindset, and flexibility to work administrative shifts as needed.

You will work in regulated environments and support validation activities across OQ, PQ, TMV, and IPM. You will use Windchill and Excel trackers to extract, review, and document validation data, ensure site alignment, and escalate risks

Qualifications

• Bachelor's in Engineering with five years of Validation experience in Medical Devices.
• Fluent in English and Spanish.
• Experience with validation lifecycle and documentation in regulated environments.

Responsibilities

• Utilize automated tools to extract and filter validation documentation (Windchill → Excel trackers).
• Review and validate extracted data to ensure accuracy, completeness, and site alignment.
• Execute detailed assessments across OQ, PQ, TMV and IPM.
• Apply technical judgment to confirm applicability of validation documentation and identify discrepancies.
• Ensure alignment with current procedures, global validation standards and remediation timelines.
• Validate that extracted data reflects site practices and documentation.
• Cross-check validation records against MVPs, PRAs and supporting validation documentation.
• Identify and quantify products requiring remediation across OQ, PQ, TMV, and IPM.
• Proactively identify data gaps, inconsistencies and tool limitations.
• Escalate risks or blockers to the core team and provide clear documentation of findings.

Skills

Bilingual English/Spanish

Positive attitude

Willing to learn

Education

Bachelor's in Engineering

Tools

Windchill

Excel

Document management systems

Job description

• Bachelor'sin Engineering with five (5) years of experiencein Validation activities within the Medial DevicesIndustry.
• 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) andSupporting validation documentation.
• Identify and quantify products requiring remediation across OQ, PQ, TMV, and IPM.
• 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 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!

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