Quality Engineer - CSV

For Quality Assurance services in the Manufacturing area.

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s degree in Natural Sciences or Engineering and a minimum of five (5) years of exposure in Quality activities within the Pharmaceutical or Medical Device Industry.
• Excellent verbal/written communication skills (English and Spanish) 
• Shift: Administrative & according to business needs 
• Experience in:
  • Validation Life Cycle (IQ, OQ, PQ, CSV) 
  • Periodic Reviews
  • Documentation
  • 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)

• Supports the implementation of effective quality engineering processes for new products, processes, and technology.
• Provides support to the validation and certification of process, test methods, equipment, software, utilities, and facilities as required, including Computer System Validation (CSV) activities.
• Generates test protocols, monitors testing, issues qualification test reports, and approves qualification plans/reports.
• Ensures periodic review of validated systems and processes to maintain compliance and identify improvement opportunities.
• 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, specifications, and provides technical transfer and validation support.
• Utilizes appropriate risk management tools to prevent unanticipated failure modes and improve 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?