CSV Lead- Automation

JC Automation, Corp.; Houston (TX); On-site; USD 120,000 - 180,000; Full time

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.

Skills

CSV Lead

Leadership

Project management

Regulatory compliance

Communication

Cross-functional teamwork

Education

Bachelor's degree in Engineering/CS or related

Tools

Emerson DeltaV

Rockwell PLC

GAMP 5

21 CFR Part 11

Kneat

AVEVA PI

FactoryTalk AssetCentre

LogMate

WIN-911

Job description

JC Automation Corp. (JCA) was founded in 1997 with the mission of filling a gap between technology and regulatory requirements in the life science manufacturing industry. The company offers highly capable resources at an affordable cost to build solutions and execute projects in: Automation, Control Systems Integration, Information Technology, System Integration and Regulatory Compliance.

JCA is a HUBZone Certified Small Business Firm, NMSDC Certified Minority Business Enterprise, and Certified Critical Industry Supplier. It’s mission is to add value by delivering quality services & solutions on time all the time by transforming processes & technology into business advantages.

Position Summary

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

The selected professional will lead CSV planning, execution, and compliance activities across multiple automation workstreams, including Emerson DeltaV DCS, Rockwell PLC systems, industrial data historians, and supporting computerized systems.

This position requires extensive experience managing CSV programs within GMP-regulated pharmaceutical environments, with strong knowledge of automation systems, validation methodologies, and regulatory requirements.

Key Responsibilities

• Lead the overall CSV strategy, planning, and execution for multiple manufacturing and infrastructure areas.
• Develop and maintain Project Validation Plans, system-specific CSV Plans, Security Plans, and Test Plans.
• Lead CSV Area Leads, Validation Engineers, Specialists, and Technical Writers.
• Establish and maintain validation schedules, resource plans, budgets, and project performance indicators.
• Apply risk-based validation methodologies aligned with GAMP 5, 21 CFR Part 11, EU Annex 11, and Computer Software Assurance principles.
• Oversee CSV activities involving Emerson DeltaV, Rockwell PLC, FactoryTalk AssetCentre, AVEVA PI, LogMate, WIN-911, and vendor-controlled equipment.
• Ensure compliance with GMP requirements, corporate quality standards, and applicable validation procedures.
• Coordinate validation activities with Automation Engineering, Quality Assurance, Manufacturing, IT/OT, MES, and Data Historian teams.
• Oversee validation of computerized system interfaces, data integrity, cybersecurity-related controls, backup/recovery, and disaster recovery requirements.
• Lead discrepancy resolution, deviation management, change control, and validation closeout activities.
• Oversee electronic validation documentation and testing using Kneat.
• Provide project progress reports, risk assessments, resource forecasts, and stakeholder updates.
• Support regulatory inspection readiness and project audits.

Required Qualifications

• Bachelor's degree in Engineering, Computer Science, or a related technical discipline, or equivalent experience.
• Minimum 10 years of CSV experience within pharmaceutical or biotechnology 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.
• Demonstrated 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.

Preferred Qualifications

• Experience with Kneat electronic validation and documentation systems.
• Experience with AVEVA PI, FactoryTalk AssetCentre, LogMate, and WIN-911.
• Experience with greenfield pharmaceutical manufacturing facilities.
• Familiarity with ISA-88, ISA-95, MES interfaces, and industrial OT infrastructure.
• Previous experience with large capital projects involving multiple manufacturing buildings.

Travel / On-Site Requirements: Regular on-site presence in Houston is preferred, with attendance based on project needs.