C&Q Automation Lead: CSV & Validation Expert

FITS LLC; Carolina (NC); On-site; USD 120,000 - 150,000; Full time

Job summary

FITS LLC seeks an experienced C&Q Technical Lead to guide automation projects in regulated environments. You will partner with process engineering, lead CSV strategy, and develop protocols (IQ/OQ/PQ) while ensuring data integrity per ALCOA+ and GAMP 5 guidelines.

Strong documentation and cross-team coordination are essential. The role requires bilingual communication in Spanish and English, with flexibility for business needs and administrative shifts.

Qualifications

• Bachelor's degree in Automation, Controls, Chemical/Electrical Engineering, Computer Science, or related field
• Spanish and English reading/writing/speaking proficiency
• Shift: Administrative and according to business needs
• Experience in automation system architecture, CSV, and regulated capital projects
• Experience reviewing documentation and supporting procurement
• Knowledge of data historians, batch reporting systems, and MES
• Experience performing P&ID reviews, prototyping, and engineering changes
• Strong understanding of CSV, GAMP 5, and data integrity (ALCOA+)
• Experience developing and executing C&Q protocols (IQ/OQ/PQ) and major CSV deliverables

Responsibilities

• Partner with process engineering to align automation requirements with business needs
• Manage technical changes and provide direction through software development and testing
• Coordinate CSV activities with QA, Automation Engineering, and Commissioning teams
• Develop CSV documentation (plans, TRMs, test scripts, summaries) compliant with GAMP 5
• Lead development and execution of C&Q protocols (IQ/OQ/PQ) for automation and control systems
• Support FAT/SAT execution and system handover to client USER teams
• Provide CSV input to schedule and progress reporting

Skills

Bilingual Spanish/English

CSV principles

GAMP 5 methodology

Validation leadership

Education

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

Tools

ALCOA+

IQ/OQ/PQ protocols

Data historians / MES

Job description

FITS LLC seeks an experienced C&Q Technical Lead to guide automation projects in regulated environments. You will partner with process engineering, lead CSV strategy, and develop protocols (IQ/OQ/PQ) while ensuring data integrity per ALCOA+ and GAMP 5 guidelines.

Strong documentation and cross-team coordination are essential. The role requires bilingual communication in Spanish and English, with flexibility for business needs and administrative shifts.