Pharma Automation Project Engineer — Lead Systems

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

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.