Validation Specialist
About The Position
This role is for Validation services within the Medical Devices Industry. The ideal candidate will have a Bachelor's degree in Life Sciences with five years of experience in Validation activities. Bilingual proficiency in English and Spanish is required. The position requires a great attitude and a strong desire to learn new skills. The shift is administrative and will be 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, and document management systems is essential.
Requirements
- Bachelor's in Life Sciences
- Five (5) years of experience in Validation activities within the Medial Devices Industry
- Bilingual: English and Spanish
- Great attitude and strong desire to learn new skills
- 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
Nice To Haves
- Treats everyone they meet like family, especially our resources, clients, and team members.
- Customer service skills
- 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to confirm applicability of validation documentation and identify discrepancies such as missing, conflicting, or outdated records.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
Number of Employees
11-50 employees
