CSV Lead for GMP Automation & Validation

JC Automation, Corp.

Houston (TX)

On-site

USD 120,000 - 180,000

Full time

13 hours ago

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Job summary

JC Automation Corp. is seeking an experienced Computer System Validation (CSV) Lead to provide strategic and technical leadership for a large-scale pharmaceutical manufacturing project in Houston, TX.

The successful candidate will oversee CSV planning, execution, and compliance across multiple automation workstreams, including Emerson DeltaV DCS, Rockwell PLC systems, data historians, and related computerized systems.

Qualifications

Bachelor's degree in Engineering, Computer Science, or related technical discipline, or equivalent experience.
Minimum 10 years of CSV experience within pharmaceutical or biotech environments.
Proven experience leading CSV activities for large pharmaceutical automation projects.
Strong understanding of GMP, GAMP 5, 21 CFR Part 11, and data integrity principles.
Experience validating Emerson DeltaV and Rockwell PLC-based automation systems.
Experience developing and executing CSV lifecycle documentation.
Strong project management, leadership, communication, and organizational skills.
Ability to manage multiple workstreams and cross-functional teams.

Responsibilities

Lead CSV strategy, planning and execution for multiple manufacturing and infrastructure areas.
Develop and maintain Project Validation Plans, system CSV Plans, Security Plans, and Test Plans.
Lead CSV Area Leads, Validation Engineers, Specialists, and Tech Writers.
Maintain validation schedules, resource plans, budgets, and performance indicators.
Apply risk-based validation aligned with GAMP 5, 21 CFR Part 11, EU Annex 11, and CSA principles.
Oversee CSV activities involving DeltaV, Rockwell PLC, and vendor systems.
Ensure GMP compliance and validation procedures are followed.
Coordinate validation with Automation Eng, QA, Manufacturing, IT/OT, MES, and Data Historian teams.
Oversee validation of interfaces, data integrity, cybersecurity controls, backup/recovery, DR requirements.
Lead discrepancy resolution, deviation management, change control, validation closeout.
Oversee electronic validation documentation and testing using Kneat.
Provide progress reports, risk assessments, and stakeholder updates.
Support regulatory inspection readiness and audits.