Process Automation Engineer

FITS LLC; Northern (KY); Hybrid; USD 110,000 - 160,000; Full time

Job summary

FITS LLC in the United States seeks a seasoned technical project leader to drive pharmaceutical automation initiatives. The role focuses on coordinating vendors, systems integrators, and internal teams across PLCs, HMIs, SCADA, DCS/BAS installations, upgrades, and commissioning.

You will troubleshoot installation issues, monitor schedules, and produce weekly status reports while collaborating with EHS, Quality, Validation, IT, and Manufacturing. Fluency in Spanish and English is required.

Qualifications

• Bachelor's degree and 5+ years in pharma ops with PM experience.
• 4+ years in process automation and 2+ years in CSV.
• Knowledge of cGMP, FDA/EMA regulations, and 21 CFR Part 1.
• Bilingual: Spanish and English.

Responsibilities

• Check in with vendors, contractors, and system integrators on active automation 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 as designs evolve.
• Move through planning, procurement, execution, commissioning, qualification, and close-out.
• Support audits, deviations, and CAPAs as needed.
• Occasionally work irregular hours during critical milestones.

Skills

Project management

Process automation

CSV

GxP / cGMP

Regulatory knowledge

Vendor coordination

Education

Bachelor's degree in Engineering/CS/IS

Tools

Maximo CMMS

Rockwell Automation

Siemens

Wonderware

FactoryTalk Batch

VMware vSphere

Syncade MES

OSIsoft PI / AVEVA PI

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?