For Validation services.
WHAT MAKES YOU A FIT:
The Technical Part:
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Bachelor's in Engineering or Sciences with three (3) years of experience in Validation activities within the Medical Devices Industry.
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Bilingual: English and Spanish
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Soft Skills: Great attitude and strong desire to learn new skills.
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Shift: Administrative, and according to business needs.
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Experience in:
- Validation (OQ/PQ/TMV/IPM)
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Validation lifecycle and documentation
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Regulated environments (FDA, ISO, GMP)
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Data analysis tools
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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).
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Review and validate extracted data to ensure accuracy, completeness, and site alignment.
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Execute detailed assessments across OQ (Operational Qualification), PQ (Performance Qualification), TMV (Test Method Validation), and IPM (In-Process Monitoring).
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Apply technical judgment to confirm the applicability of validation documentation and identify discrepancies such as missing, conflicting, or outdated records.
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Ensure alignment with current procedures, global validation standards, and remediation expectations and timelines.
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Validate that extracted data accurately reflects site practices and documentation.
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Cross-check validation records against MVPs (Master Validation Plans), PRAs (Product Risk Assessments), and supporting validation documentation.
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Identify and quantify products requiring remediation across OQ, PQ, TMV, and IPM.
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Highlight high-risk, complex, or ambiguous scenarios requiring deeper analysis.
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Proactively identify data gaps, inconsistencies, and tool limitations.
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Escalate risks, uncertainties, or blockers to the core team promptly.
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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?
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