Validation Specialist

For Validation services WHAT MAKES YOU A FIT: The Technical Part: Bachelor's in Engineering with five (5) years of experience in Validation activities within the Medial Devices Industry. 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to: Confirm applicability of validation documentation and identify discrepancies such as missing, conflicting, or outdated records.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) 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. 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?