Automation & CSV Lead: C&Q Strategy & Validation Expert

fitspr; Carolina (PR); On-site; USD 120,000 - 180,000; Full time

Job summary

FITS, a service provider, seeks a C&Q Technical Lead for automation in pharma/biotech environments on the island and in the US. This role requires bilingual Spanish/English communication, a strong background in CSV/GAMP5, IQ/OQ/PQ, and leading commissioning and qualification activities.

You will partner with process engineering, manage CSV strategy, review vendor documentation, and ensure data integrity and regulatory compliance across projects.

Qualifications

• Bachelor's degree in Automation, Controls, Chemical/Electrical Engineering, Computer Science, or a related field.
• Bilingual Spanish and English required.
• Experience in pharma/biotech regulated environments.
• Strong CSV, GAMP5, and data integrity knowledge.
• Experience leading CSV and C&Q activities.

Responsibilities

• Partner with process engineering to align automation with business needs.
• Lead and manage CSV strategy and major deliverables.
• Direct C&Q protocols (IQ/OQ/PQ) development and execution.
• Coordinate with QA, Automation Engineering, and Commissioning teams.
• Support FAT/SAT execution and system handover.

Skills

Bilingual Spanish/English

CSV/GAMP5 knowledge

C&Q protocols IQ/OQ/PQ

Validation planning

Regulatory/compliance

Education

Bachelor's degree in Automation/Controls/Chemical/Electrical Eng or CS

Tools

MES

Data Historians

Job description

FITS, a service provider, seeks a C&Q Technical Lead for automation in pharma/biotech environments on the island and in the US. This role requires bilingual Spanish/English communication, a strong background in CSV/GAMP5, IQ/OQ/PQ, and leading commissioning and qualification activities.

You will partner with process engineering, manage CSV strategy, review vendor documentation, and ensure data integrity and regulatory compliance across projects.