Project Engineer - Automation

FITS LLC; Puerto Rico; On-site; USD 90,000 - 130,000; Full time

Job summary

FITS LLC is seeking a senior technical program professional with extensive pharmaceutical operations and process automation experience to lead complex projects across the island. You will coordinate PLC/HMI/SCADA installations, manage vendors, and ensure regulatory compliance (cGMP, FDA/EMA, 21 CFR Part 1) while guiding teams through CSV and validation activities.

You will collaborate with EHS, Quality, and Manufacturing, deliver weekly status reports, and support audits and CAPAs.

Qualifications

• Bachelor's degree in Engineering, Computer Science, Information Systems, or related field.
• 5+ years in pharmaceutical operations/manufacturing with project management experience.
• 4+ years in process automation.
• 2+ years in CSV.
• Strong knowledge of cGMP, FDA/EMA regulations, and 21 CFR Part 1.
• Bilingual: Spanish and English (verbal/written)
• Shift: Administrative and per business needs.

Responsibilities

• Check in with vendors, contractors, and system integrators on active automation/IT projects.
• Troubleshoot technical issues during installation, start-up, or qualification activities.
• Monitor project schedules and flag risks or delays to stakeholders.
• Coordinate with EHS, Quality, and Manufacturing on day-to-day project matters.
• Prepare and present weekly project status reports (milestones, budget, risks).
• Attend cross-functional meetings with Engineering, Quality, Validation, IT, and Manufacturing.
• Review vendor quotes and update technical documentation (URS, FRS, DS).
• Move through project phases — planning/desing, procurement, execution/construction, commissioning/qualification (FAT/SAT, CSV, PQ), and close-out.
• Support audits, deviations, and CAPAs as needed.
• Occasionally work irregular hours during critical milestones (start-up, cutover, audits).

Skills

bilingual Spanish-English

Education

Bachelor's degree in Engineering/CS/IS

Tools

Maximo

Rockwell Automation

Siemens

Wonderware

FactoryTalk Batch

VMware vSphere

Syncade

OSIsoft/AVEVA PI

.NET/SQL databases

Job description

WHAT MAKES YOU A FIT:

The Technical Part:

• Bachelor's degree in Engineering, Computer Science, Information Systems, or related field. 5+ years in pharmaceutical operations/manufacturing with project management experience, including 4+ years in process automation and 2+ years in CSV.


• Strong knowledge of cGMP, FDA/EMA regulations, and 21 CFR Part 1


• Bilingual: Spanish and English (verbal/ written)


• Shift: Administrative and according to business needs.


• Experience in:
  
  
  • CMMS systems (e.g., Maximo).
  
  
  • High level of expertise in Rockwell Automation platforms.
  
  
  • Siemens, Wonderware, and FactoryTalk Batch.
  
  
  • Virtualization platforms (VMware vSphere).
  
  
  • MES systems (e.g., Syncade).
  
  
  • OSIsoft / AVEVA PI systems and Microsoft SQL databases.
  
  

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 of 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)

• Check in with vendors, contractors, and system integrators on active automation/IT projects (PLCs, HMI, SCADA, DCS/BAS installations, upgrades, commissioning).


• Troubleshoot technical issues that come up during installation, start-up, or qualification activities.


• Monitor project schedules and flag risks or delays to stakeholders.


• Coordinate with EHS, Quality, and Manufacturing on day-to-day project matters.


• Prepare and present weekly project status reports (milestones, budget, risks).


• Attend cross-functional meetings with Engineering, Quality, Validation, IT, and Manufacturing.


• Review vendor quotes and update technical documentation (URS, FRS, DS) as designs evolve.


• Move through project phases — planning and design, procurement, execution/construction, commissioning and qualification (FAT/SAT, CSV, PQ), and close-out.


• Support audits, deviations, and CAPAs as needed.


• Occasionally work irregular hours during critical milestones (start-up, cutover, audits)

WHO WE ARE:

We are a Service Provider company, different from the rest. We pride ourselves onhow 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 industryclients with top-notch quality talent. We're FITS!

Are you the Next Piece?