Automation Validation Lead — CSV & C&Q for Pharma Systems

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

Job summary

FITS, LLC in Puerto Rico is seeking a CSV/QA professional to lead commissioning and qualification for automation and control systems in a regulated environment. You will develop validation plans, design and test scripts, and ensure data integrity per ALCOA+ and GAMP 5.

You will coordinate with QA, automation, and commissioning teams, manage deviations and change controls, and prepare CSV training materials. Fluent in Spanish and English is required.

Qualifications

• Bachelor's degree or equivalent in a technical field.
• Bilingual in Spanish and English (reading/writing/speaking).
• Shift: Administrative and according to business needs.
• Experience in automation systems within pharma/biotech or regulated capital projects.
• Experience reviewing control system documentation and vendor documentation.
• Knowledge of data historians, batch reporting, and MES.

Responsibilities

• Partner with process engineering to align requirements with business needs.
• Lead CSV strategy, validation plans, and major deliverables (IQ/OQ/PQ, Design, Test Plans).
• Coordinate CSV activities with QA, Automation Engineering, and Commissioning teams.
• Develop and maintain CSV documentation compliant with GAMP 5 and Lilly procedures.
• Support FAT/SAT execution and system handover to client teams.
• Provide CSV input to schedule and milestone tracking.
• Manage deviations, discrepancies, and change controls.
• Develop CSV training materials and matrices for the team.

Skills

Automation architecture

CSV & GAMP5

IQ/OQ/PQ validation

Documentation management

ALCOA+ data integrity

Change control

Cross-functional collaboration

Spanish/English bilingual

Education

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

Job description

FITS, LLC in Puerto Rico is seeking a CSV/QA professional to lead commissioning and qualification for automation and control systems in a regulated environment. You will develop validation plans, design and test scripts, and ensure data integrity per ALCOA+ and GAMP 5.

You will coordinate with QA, automation, and commissioning teams, manage deviations and change controls, and prepare CSV training materials. Fluent in Spanish and English is required.