C&Q Automation Lead — CSV & Validation Expert

FITS LLC; Carolina (PR); On-site; USD 90,000 - 130,000; Full time

Job summary

FITS LLC is seeking a highly skilled CSV professional to lead validation activities for automation and control systems in our pharmaceutical and manufacturing projects across the US and Caribbean.

You will develop and execute IQ/OQ/PQ protocols, create validation plans, traceability matrices, and ensure compliance with GAMP 5 and Lilly quality system procedures, coordinating with QA and engineering teams.

Qualifications

• Bachelor's degree in Automation, Controls, Chemical/Electrical Engineering, Computer Science, or related field.
• Excellent reading, writing, and speaking skills in Spanish and English.
• Experience with CSV principles and data integrity (ALCOA+).
• Experience developing and executing IQ/OQ/PQ and CSV deliverables.
• Knowledge of MES, batch reporting, and data historians.

Responsibilities

• Partner with process engineering to ensure automation requirements are aligned with business needs.
• Manage technical changes and provide technical direction through all software development and testing activities.
• Partner with the Design Verification Lead to ensure alignment between CSV and verification expectations.
• Provide direction for CSV strategy, validation approach, and major CSV deliverables (Requirements, Design, Security Plan, Test Plan, etc.).
• Lead development and execution of Commissioning and Qualification (C&Q) protocols (IQ/OQ/PQ) for automation and control systems.
• Develop all related CSV documentation (validation plans, requirements traceability matrices, test scripts, summary reports), ensuring it complies with GAMP 5 and Lilly quality system procedures.
• Coordinate CSV activities with Quality Assurance, Automation Engineering, and Commissioning teams to support project schedule and data integrity requirements.
• Manage deviations, discrepancies, and change controls associated with C&Q and CSV activities.
• Develop and maintain CSV training materials and matrices for the CSV team, automation integrator, CSV service provider, and Client USER groups.
• Support FAT/SAT execution and assist with system handover to the Client USER team.
• Provide CSV input to the C&Q schedule and progress reporting, including system definition/classification and baseline CSV milestones.

Skills

Spanish-English bilingual

Customer service mindset

Team collaboration

Education

Bachelor's degree in Automation, Controls, Chemical/Electrical Engineering, Computer Science, or related field

Tools

GAMP 5

CSV protocols

IQ/OQ/PQ

P&ID reviews

MES

Job description

FITS LLC is seeking a highly skilled CSV professional to lead validation activities for automation and control systems in our pharmaceutical and manufacturing projects across the US and Caribbean.

You will develop and execute IQ/OQ/PQ protocols, create validation plans, traceability matrices, and ensure compliance with GAMP 5 and Lilly quality system procedures, coordinating with QA and engineering teams.