Quality Engineer - CSV

 For Quality services in the Engineering & Manufacturing areas. 

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor's Degree in Engineering and at least four (4) years of previous exposure in CSV and Periodic Review activities within the Pharmaceutical or Medical Devices industry. 
• Bilingual, Spanish and English (good communications)
• Shift: Administrative & according to business needs 
• Experience in:
  • Validation Life Cycle (CSV) 
  • Change control 
  • Periodic Reviews
  • GMP & GDP 

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)

• Support the implementation of effective quality engineering processes for new products, processes, and technology.
• Provides support to the validation and certification of processes, test methods, equipment, software, utilities, and facilities as required.
• Generates test protocols, monitors testing, issues qualification test reports, and approves qualifications plans/reports.
• Provides support on activities, documents, and records requiring Quality Engineering review and/or approval as deemed necessary.
• Alerts the organization to issues in time to resolve potential adverse effects on the customer, company image, or reputation of the business.
• Works with multi-functional teams to establish project plans and ensures uninterrupted support to new projects balanced with manufacturing operations.
• Develops standard operating procedures, and specifications, and provides technical transfer and validation support.
• Utilizes appropriate risk management tools to prevent unanticipated failure modes and improve the capability of processes. 

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?