Project Engineer

For Facilities Process Engineer services in the Manufacturing area.

WHAT MAKES YOU A FIT: 

The Technical Part:

• Bachelor’s Degree in Engineering or related technical field and at least six (6) years of experience to Facilities, Utilities & Capital Projects activities within the Pharmaceutical or Medical Devices industry. 
• Bilingual (Spanish and English)
• Shift: Administrative & according to business needs 
• Experience in:
  • HVAC Systems, HEPA Filtration Systems, Compressed Air Systems & Building Automation Systems (BAS/BMS)
  • Generating and executing:  URS, FRS, SDS, FAT/SAT, IQ, OQ, PQ Protocols, Validation Plans and Reports, & Traceability Matrices.
  •   Computer System Validation (CSV) experience required
  • FDA, GMP, ISO, OSHA, EPA, and GAMP 5 requirements
  • Technical writing, troubleshooting, and project management

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 facility and utility projects from planning through validation and implementation.
• Develop and execute validation deliverables including URS, FRS, SDS, FAT, SAT, IQ, OQ, and PQ protocols.
• Participate in risk assessments, change controls, deviations, CAPAs, and investigations.
• Analyze validation data and generate technical reports.
• Troubleshoot facility, utility, automation, and computerized systems.
• Support equipment installation, commissioning, startup, and qualification activities.
• Coordinate with Engineering, Quality, Operations, Regulatory Affairs, and external vendors.
• Ensure compliance with FDA, GMP, ISO, OSHA, EPA, and internal procedures.
• Participate in audits and support continuous improvement initiatives.

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?