Validation Engineer

For Validation services in the Quality/Validation area. 

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s degree in Engineering and at least two (2) years of previous experience in Validation activities within the Pharmaceutical & Medical Devices Industry.
• Bilingual: Spanish and English
• Soft Skills: Excellent communication skills and a positive attitude. 
• Shift: Administrative and according to business needs
• Experience in:
  • Validation Life Cycle (IQ, OQ, PQ) 
  • Manufacturing processes, equipment, cleaning, and computerized systems validation
  • Regulatory requirements and standards (FDA, ISO, cGMP)
  • Statistical analysis tools (e.g., Minitab, Excel)
  • Change Control and validation impact assessments

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 Be The Piece?

AS A PIECE OF FITS, YOU WILL: (The day-to-day on the job) 

• Develop, execute, and document validation protocols and reports, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Support validation activities for manufacturing processes, equipment, cleaning procedures, and computerized systems.
• Participate in equipment qualification, requalification, and validation lifecycle activities to ensure compliance and operational readiness.
• Perform validation impact assessments associated with Change Controls (CN/CR) and support implementation activities.
• Collaborate with cross-functional teams including Manufacturing, Quality, Engineering, R&D, and Regulatory Affairs to support validation projects.
• Analyze validation data using statistical tools and methodologies to support conclusions and recommendations.
• Support protocol deviations, investigations, corrective actions, and continuous improvement initiatives.
• Maintain accurate validation documentation in compliance with Good Documentation Practices (GDP) and applicable regulations.
• Support internal audits and regulatory inspections by providing validation documentation and technical expertise.
• 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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