Validation Specialist

Flexible & Integrated Technical Services, LLC • Dorado, PR

5d

About The Position

This role is for Validation services. The ideal candidate will have a Bachelor's degree in Engineering or Sciences with three years of experience in Validation activities within the Medical Devices Industry. The position requires bilingual proficiency in English and Spanish, a great attitude, and a strong desire to learn new skills. The shift is administrative and according to business needs.

Requirements

• Bachelor's in Engineering or Sciences
• Three (3) years of experience in Validation activities within the Medical Devices Industry
• Bilingual: English and Spanish
• Experience in Validation (OQ/PQ/TMV/IPM)
• Experience in Validation lifecycle and documentation
• Experience in Regulated environments (FDA, ISO, GMP)
• Experience with Data analysis tools
• Experience with Document management systems
• Great attitude
• Strong desire to learn new skills

Nice To Haves

• Treats everyone they meet like family
• Customer service skills
• Eager to innovate
• Brings top-quality results

Responsibilities

• 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to confirm the applicability of validation documentation and identify discrepancies such as missing, conflicting, or outdated records.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 promptly.
• Provide clear documentation of findings and recommended actions.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level