For Project Engineering services in the Compressed Air & Utilities areas. 

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor's Degree in Engineering and a minimum of six (6) years of experience within the Pharmaceutical or Medical Devices industry. 
• Bilingual: Spanish and English 
• Shift: Administrative & according to business needs 
• Experience in:
  • Facility Validation
  • HIPPA Filtration 
  • Generating and executing validation documentation (URS, FRS, SDS, IQ/OQ/PQ, Validation Plans, SOPs).
  • FDA, GMP, ISO, OSHA, EPA requirements, and GAMP 5 Computer Systems Validation lifecycle.

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)

• Plan, develop, and implement documentation, procedures, and training programs to support the Engineering and Validation teams.
• Lead and actively participate in the Computer Systems Validation (CSV) Life Cycle for regulated projects, including requirements definition, risk assessments, traceability, protocol development, testing, and deviation management.
• Generate and maintain validation documentation such as Validation Plans, URS, FRS, SDS, Traceability Matrix, validation protocols (FAT/SAT/IQ/OQ/PQ), and final reports.
• Perform and document validation testing, statistical data analysis, and develop statistically based sampling plans for inspections and validations.
• Review and approve validation protocols, executions, and completion reports for new and existing automated and computerized systems.
• Troubleshoot automation and computer system issues encountered during validation activities and recommend process or quality improvements.
• Investigate, document, and resolve non-conformances, protocol deviations, and CAPAs, ensuring timely and compliant closure.
• Manage equipment installation, automation software modifications, vendor coordination, budgeting, procurement, training, and system start-ups.
• Lead validation process improvement initiatives, oversee validation contractors, and generate performance metrics and trending reports for management reviews.
• Collaborate cross-functionally with Manufacturing, Engineering, Quality, Regulatory, and external partners, and support regulatory submissions and inspections (FDA, ISO, Notified Bodies, corporate audits).

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?