For Validation services in the Quality/Validation area.
WHAT MAKES YOU A FIT:
The Technical Part:
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Bachelor’s degree in Engineering and at least two (2) years of previous experience in Validation activities within the Pharmaceutical & Medical Devices Industry.
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Bilingual: Spanish and English
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Soft Skills: Excellent communication skills and a positive attitude.
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Shift: Administrative and according to business needs
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Experience in:
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Validation Life Cycle (IQ, OQ, PQ)
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Manufacturing processes, equipment, cleaning, and computerized systems validation
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Regulatory requirements and standards (FDA, ISO, cGMP)
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Statistical analysis tools (e.g., Minitab, Excel)
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Change Control and validation impact assessments
The Personality Part:
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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 Be The Piece?
AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job)
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Develop, execute, and document validation protocols and reports, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
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Support validation activities for manufacturing processes, equipment, cleaning procedures, and computerized systems.
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Participate in equipment qualification, requalification, and validation lifecycle activities to ensure compliance and operational readiness.
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Perform validation impact assessments associated with Change Controls (CN/CR) and support implementation activities.
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Collaborate with cross-functional teams including Manufacturing, Quality, Engineering, R&D, and Regulatory Affairs to support validation projects.
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Analyze validation data using statistical tools and methodologies to support conclusions and recommendations.
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Support protocol deviations, investigations, corrective actions, and continuous improvement initiatives.
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Maintain accurate validation documentation in compliance with Good Documentation Practices (GDP) and applicable regulations.
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Support internal audits and regulatory inspections by providing validation documentation and technical expertise.
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Track validation project timelines, deliverables, and status updates to ensure successful execution.
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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