CSV/C&Q Automation Lead — Pharma Validation

JC Automation

Carolina (PR)

On-site

USD 120,000 - 190,000

Full time

20 hours ago

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Job summary

JC Automation Corp. is seeking a CSV C&Q Technical Lead to define, develop, and deliver CSV requirements, documentation, and input throughout the lifecycle of capital projects in the life science sector.

You will own the development of CSV deliverables, manage validation activities, and collaborate with CQV leads, engineers, operations, and external vendors to ensure regulatory compliance and data integrity.

Qualifications

Bachelor’s degree in engineering or related field.
Experience directing automation architecture in pharma/biotech capital projects.
Knowledge of CSV and GAMP5, data integrity (ALCOA+) requirements.
Experience developing and executing C&Q protocols (IQ/OQ/PQ).
Ability to coordinate with Design Verification, Process Engineering, QA, and Commissioning teams.

Responsibilities

Define and deliver CSV requirements and documentation.
Develop and execute C&Q protocols (IQ/OQ/PQ) for automation.
Coordinate CSV activities with QA, Automation, and Commissioning teams.
Ensure CSV compliance with GAMP 5 and data integrity standards.
Develop validation plans, requirements traceability matrices, test scripts, and summary reports.
Support FAT/SAT and handover to Client USER team.
Lead deviations and change control for CSV activities.