Pharma Process Automation Lead (CSV/SCADA)

FITS LLC; Puerto Rico; On-site; USD 90,000 - 120,000; Full time

Job summary

FITS LLC is seeking an experienced automation professional for Capital Project initiatives in the pharma/manufacturing sector. You will engage with vendors, integrators, and internal teams to drive PLC/HMI/SCADA/DCS implementations, qualification, and commissioning.

The role requires strong PM skills, cGMP knowledge, and bilingual Spanish/English communication. Expect cross-functional collaboration, periodic long hours during critical milestones, and a focus on delivering high-quality results.

Qualifications

• Bachelor's degree in Engineering or related field required.
• 5+ years in pharmaceutical ops/manufacturing with PM experience.
• 4+ years in process automation and 2+ years in CSV.
• Strong knowledge of cGMP, FDA/EMA, and 21 CFR Part 11.

Responsibilities

• Check in with vendors, contractors, and system integrators on active automation/IT projects (PLCs, HMI, SCADA, DCS/BAS).
• Troubleshoot issues during installation, start-up, or qualification activities.
• Monitor project schedules and flag risks/delays to stakeholders.
• Coordinate with EHS, Quality, and Manufacturing on day-to-day 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 URS/FRS/DS as designs evolve.
• Move through project phases: planning, procurement, execution, commissioning, qualification (FAT/SAT, CSV, PQ), close-out.
• Support audits, deviations, and CAPAs as needed.
• Occasionally work irregular hours during critical milestones.

Skills

Project management

Vendor coordination

Bilingual: Spanish/English

Problem solving

Education

Bachelor's degree in Engineering or related field

Tools

Rockwell Automation

Siemens

Wonderware

FactoryTalk Batch

VMware vSphere

MES systems (Syncade)

OSIsoft/AVEVA PI

MS SQL databases

Job description

FITS LLC is seeking an experienced automation professional for Capital Project initiatives in the pharma/manufacturing sector. You will engage with vendors, integrators, and internal teams to drive PLC/HMI/SCADA/DCS implementations, qualification, and commissioning.

The role requires strong PM skills, cGMP knowledge, and bilingual Spanish/English communication. Expect cross-functional collaboration, periodic long hours during critical milestones, and a focus on delivering high-quality results.