Validation Specialist

 For Validation services in the manufacturing area. 

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s Degree in Engineering and two (2+) years of experience in the regulated industry. 
• Bilingual: Spanish and English
• Soft Skills: Organizational skills 
• Shift: Administrative and according to business
• Experience:
  • Experience in the validation lifecycle.
    Generation and execution of protocols for manufacturing equipment validations (ovens, sealers, injection molding).
  • GMP and FDA 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 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)

• Develop and execute validation protocols for packaging and manufacturing processes.
• Conducted risk assessments and implemented mitigation strategies for equipment and processes.
• Ensure compliance with industry regulations, quality standards, and Good Manufacturing Practices (GMP).
• Collaborate with cross-functional teams to optimize packaging and manufacturing systems.
• Perform testing and analysis to validate packaging materials and manufacturing equipment.
• Document validation activities, including protocols, reports, and standard operating procedures.
• Identify and resolve non-compliance issues or process inefficiencies.
• Stay updated on advancements in packaging technologies and manufacturing practices.
• Train personnel on validation procedures and regulatory requirements.
• Support audits and inspections by providing validation documentation and expertise.

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 Devic,e and Manufacturing industry clients with top-notch quality talent. We're FITS! 

Are you the next piece?