Validation Engineer

 For Validation services in the Process Development department. 

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s Degree in Engineering and at least four (4) years of experience in the medical devices industry. 
• Bilingual: Spanish and English
• Soft Skills: Writing skills 
• Shift: Administrative and according to business
• Experience:
  • Validation Life Cycle
  • Lasers 
  • GMP & GDP regulations

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 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)

• Conduct process equipment installation/operational/performance qualification studies to test their functionality.
• Prepare operational qualification assessments to support that validated critical operating parameters are within qualified parameters.
• Identify and evaluate equipment enhancements to support intended qualified operational ranges.
• Support the evaluation of Change Controls to establish qualification assessments and performance qualification requirements during process and/or equipment modifications.
• Support process capability and statistical analysis related to equipment performance.
• Support the periodic review of equipment/system qualifications studies.
• Generate & execute protocols: IQ, OQ, PQ.
• Generate and execute equipment/software validation protocols (IQ, TMV, TQF), Process Characterization, and Process Validation based on equipment capabilities.
• Validation engineering support of process and/or equipment upgrades, replacements, and modifications in the manufacturing environment.
• Develop, organize, analyze, and present interpretations of results for operational issues or validation engineering projects of significant scope and complexity.

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?