Validation Engineer
Flexible & Integrated Technical Services, LLC•Dorado, PR
•Onsite
About The Position
We are seeking a Validation Engineer to join our Validation services team. This role is crucial for ensuring the accuracy, completeness, and compliance of validation documentation within the Medical Devices Industry. The ideal candidate will have a strong technical background in validation activities, excellent analytical skills, and a customer-service-oriented mindset. You will be responsible for utilizing automated tools, reviewing data, executing validation assessments, and ensuring alignment with regulatory standards.
Requirements
- Bachelor's in Engineering
- Five (5) years of experience in Validation activities within the Medial Devices Industry
- Bilingual: English and Spanish
- Experience in Validation (OQ/PQ/TMV/IPM)
- Experience in Quality Engineering or Manufacturing Engineering
- 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 and strong desire to learn new skills
- Customer service skills
Nice To Haves
- Treats everyone they meet like family
- Customer service pro
- Full of bright ideas and eager to innovate
- Always bringing top-quality results to the table
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to confirm applicability of validation documentation and identify discrepancies such as missing, conflicting, or outdated records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
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
