CSV/C&Q Technical Lead — Pharma Automation

ADP, Inc.; Carolina (PR); On-site; USD 120,000 - 180,000; Full time

Job summary

JC Automation Corp. (JCA) is seeking a CSV C&Q Technical Lead to define, develop and deliver its CSV requirements and documentation throughout the project lifecycle.

You will lead the development and approval of CSV plans, requirements, and test scripts for automation and control systems. You will collaborate with CQV leads and engineering teams to ensure alignment with GAMP 5, ALCOA+ data integrity and regulatory expectations, driving CSV strategy and major deliverables from design through

Qualifications

• Bachelor's degree or equivalent in a related engineering/technical field required.
• Experience with automation system architecture and regulated capital projects in pharma/biotech is required.
• Knowledge of CSV, GAMP 5, data integrity (ALCOA+) essential.
• Familiarity with MES, historians, and batch reporting is preferred.
• Experience developing and executing C&Q protocols (IQ/OQ/PQ) and validation deliverables.

Responsibilities

• Define, develop and deliver CSV requirements, documentation and input for the C&Q program.
• Own development, review and approval of CSV requirements, test plans, specs and documentation.
• Coordinate with CQV leads, engineers, operations, vendors and contractors to meet CSV objectives.
• Ensure CSV objectives align with QA, validation and HSE throughout project lifecycle.
• Support FAT/SAT and handover to Client USER teams.

Skills

Automation system architecture

CSV principles

GAMP 5

Data historians / MES

P&ID reviews

Leadership

Education

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

Tools

IQ/OQ/PQ protocols

Validation plans

Requirements traceability matrices

Job description

JC Automation Corp. (JCA) is seeking a CSV C&Q Technical Lead to define, develop and deliver its CSV requirements and documentation throughout the project lifecycle.

You will lead the development and approval of CSV plans, requirements, and test scripts for automation and control systems. You will collaborate with CQV leads and engineering teams to ensure alignment with GAMP 5, ALCOA+ data integrity and regulatory expectations, driving CSV strategy and major deliverables from design through