Validation Engineer

For Validation services in the Manufacturing areas.

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s Degree in Engineering and at least four (4) years of exposure to Validation Engineering activities within the Pharmaceutical or Medical Devices industry. 
• Bilingual (Spanish and English)
• Shift: Administrative & according to business needs 
• Experience in:
  • FDA, OSHA, EPA, GMPs, ISO requirements, and regulatory guidelines (GAMP 5, FDA).
  • Computer Systems Validation Life Cycle, including generating Validation Plans, URS, FRS, SDS, traceability matrix, and protocols (IQ/OQ/PQ).
  • Verification and validation processes, risk assessments, statistical analysis, and Lean/Six Sigma methodologies.
  • Project Management and Technical Documentation 

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)

• Develop and implement documentation, procedures, and training for engineering and validation activities.
• Participate in the Validation Life Cycle: review documentation, define requirements, perform risk assessments, and manage deviations.
• Generate and execute validation plans, protocols (FAT/SAT/IQ/OQ/PQ), and completion reports.
• Perform statistical analysis and develop sampling plans for testing and inspections.
• Review and approve validations for new and existing computer and automation systems.
• Manage installation of equipment and software modifications, including vendor coordination and troubleshooting.
• Lead process improvement projects and oversee validation contractor resources.
• Prepare metrics and reports for Quality Management Reviews and Operational Reviews.
• Ensure compliance with regulatory agencies and participate in audits (FDA, ISO, Notified Body).
• Investigate and document non-conformances, CAPAs, and prepare investigation reports.

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?