Validation Services PositionThe Technical Part:Bilingual: English and SpanishSoft 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 EngineeringValidation lifecycle and documentationRegulated environments (FDA, ISO, GMP)Data analysis toolsDocument management systemsThe 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: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 alignmentExecute 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to: Confirm applicability of validation documentation and identify discrepancies such as missing, conflicting, or outdated records.Ensure alignment with: Current procedures, global validation standards and Remediation expectations and timelines.Validate that extracted data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 documentationCross-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?