Pharma Process Automation Engineer - CSV & Project PM

FITS, LLC

Manatí (PR)

On-site

USD 90,000 - 120,000

Full time

5 days ago

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Job summary

FITS, LLC in Puerto Rico seeks an experienced automation specialist for the Capital Project area. You will oversee project activities, collaborate with Engineering, Quality, and IT, and ensure commissioning and qualification steps (FAT/SAT, CSV) are met.

With a Bachelor's in engineering/computer science and 5+ years in pharma operations plus 4+ years in process automation, you will address vendor coordination, system integration, and project reporting.

Qualifications

Bachelor's degree in Engineering, Computer Science, Information Systems, or related field.
5+ years in pharmaceutical operations/manufacturing with project management experience.
2+ years in CSV (Computer System Validation).

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/delays to stakeholders.
Coordinate with EHS, Quality, and Manufacturing on 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/design, procurement, execution/construction, commissioning/qualification (FAT/SAT, CSV, PQ), and close-out.
Support audits, deviations, and CAPAs as needed.