Commissioning & Qualification Specialist

For C&Q services in the Manufacturing and Engineering area.

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s Degree in Life Sciences or Engineering and previous exposure to Validation and/or Qualification activities within the pharmaceutical and medical devices industry. 
• Bilingual: (Spanish and English)
• Shift: Administrative & according to business needs
• Experience in:
  • Validation principles, protocols (IQ, OQ, PQ, CSV), and lifecycle management
  • Manufacturing equipment. (Fette, CTC)
  • 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)

• Execute and manage the qualification lifecycle for equipment and processes, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
• Develop, review, and execute validation protocols and reports in accordance with GMP and company standards.
• Generate and maintain change control documentation for equipment and process modifications.
• Perform troubleshooting and root cause analysis for validation-related issues.
• Ensure compliance with Good Manufacturing Practices (GMP) and regulatory requirements throughout all validation activities.
• Collaborate with manufacturing, packaging, and quality teams to support equipment qualification and process improvements.
• Maintain accurate and timely documentation in alignment with internal SOPs and regulatory expectations.

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?