CSV/C&Q Technical Lead — Pharma Automation
ADP, Inc.
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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
Education
Tools
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
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