Pharma Process Automation Engineer – CSV & MES Expert

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

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.