CSV & C&Q Technical Lead - Pharma Automation

JC Automation Corp.; Carolina (PR); On-site; USD 130,000 - 190,000; Full time

Job summary

JC Automation Corp. seeks a CSV Lead to define and deliver the CSV program across lifecycle, from design through handover. You will own validation plans, requirements, and test scripts for automation and process equipment.

You will collaborate with CQV leads, process engineers, QA, and commissioning teams to ensure data integrity, regulatory compliance, and successful project delivery on tight schedules.

Qualifications

• Bachelor's degree in Automation, Controls, Chemical/Electrical Engineering, Computer Science, or related field.
• Experience in automation system architecture in regulated pharma/biotech projects.
• Experience reviewing vendor documentation and procurement support.
• Knowledge of data historians, MES, and batch reporting.
• Experience performing P&ID reviews, prototyping, and engineering changes.
• Strong CSV/GAMP5 understanding and data integrity (ALCOA+) requirements.
• Experience developing C&Q protocols and major CSV deliverables.
• Ability to collaborate with Design Verification, Process Engineering, QA, and Commissioning.

Responsibilities

• Define, develop, and deliver CSV requirements and documentation across lifecycle.
• Own CSV test plans, specifications, and validation deliverables.
• Coordinate with CQV leads, engineers, operations, vendors, and integrators.
• Lead development and execution of IQ/OQ/PQ for automation and control systems.
• Ensure CSV compliance with GAMP5 and Lilly quality procedures.
• Support FAT/SAT execution and handover to Client USER team.
• Provide CSV guidance during project phases and milestones.

Skills

Automation architecture

CSV principles

GAMP 5

Project leadership

Data integrity

Regulatory compliance

Education

Bachelor's degree in Engineering

Job description

JC Automation Corp. seeks a CSV Lead to define and deliver the CSV program across lifecycle, from design through handover. You will own validation plans, requirements, and test scripts for automation and process equipment.

You will collaborate with CQV leads, process engineers, QA, and commissioning teams to ensure data integrity, regulatory compliance, and successful project delivery on tight schedules.