CSV Lead Position

Job Description

Job Description

About Company:

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.

ABOUT THE ROLE

We are seeking an experienced CSV Lead to provide leadership, coordination, and execution support for validation activities associated with a DeltaV Upgrade Project within a GMP-regulated pharmaceutical manufacturing environment. This role is responsible for ensuring full compliance with applicable standards and regulatory requirements, including cGMP, 21 CFR Part 11, GAMP 5 guidance, data integrity principles, and corporate quality standards.

The ideal candidate brings deep hands-on experience with DeltaV DCS validation, proven proficiency with Veeva Vault and electronic ALM platforms such as Kneat, and the cross-functional leadership skills to maintain strategic alignment with Engineering, Quality, and Project Management teams throughout the project lifecycle.

RESPONSIBILITIES

• CSV Leadership & Coordination: Lead and coordinate validation activities associated with DeltaV DCS upgrades, implementations, and lifecycle management. Maintain visibility of overall CSV performance, execution planning, and timeline management in alignment with the DeltaV Upgrade Team and other CSV Teams.
• Validation Package Execution: Review, develop, execute, and deliver complete validation packages for each applicable system, including Validation Plans, Design Specification Documents (DSD), Requirements Traceability Matrices (RTM), IQ/OQ protocols, Data Migration Strategies, Test Scripts, Test Summary Reports, and all supporting validation documentation.
• Document Control (Veeva): Serve as Document Controller for all CSV documentation. Upload, review, and approve all validation documents in Quality Docs (Veeva), ensuring proper routing and lifecycle management in accordance with data integrity standards.
• Electronic Test Execution: Execute validation electronically using Application Lifecycle Management (ALM) tools (e.g., Kneat or equivalent). Generate, approve, execute, and verify test scripts electronically; manage defects through the same electronic platform in accordance with applicable procedures.
• Regulatory Compliance: Ensure all validation activities comply with cGMP, FDA 21 CFR Part 11, GAMP 5 methodology, and corporate data integrity and quality standards throughout the project lifecycle.
• Cross-Functional Collaboration: Coordinate cross-functional validation efforts and maintain strategic alignment with Engineering, Quality, and Project Management teams. Lead or support project governance meetings and escalate risks and issues as needed to ensure timely execution.

REQUIREMENTS & QUALIFICATIONS

Required

• Bachelor’s degree (B.S. or B.A.) in Engineering (Computer, Electrical, Chemical), Computer Science, Life Sciences, or a closely related technical field.
• Minimum 4 years of progressive, hands-on experience in Computer System Validation (CSV) or Automation Quality within the pharmaceutical or biotechnology manufacturing industry.
• Proven track record leading validation activities specifically associated with Emerson DeltaV DCS upgrades, implementations, or lifecycle management.
• Deep knowledge of cGMP, FDA 21 CFR Part 11, GAMP 5, data integrity principles, and corporate quality standard enforcement.
• Extensive experience authoring, reviewing, and approving end-to-end validation packages including Validation Plans, DSDs, RTMs, IQ/OQ protocols, Data Migration Strategies, and Test Summary Reports.
• Direct experience as Document Controller or power user within Veeva Vault (QualityDocs) for uploading, managing, and routing CSV documentation for approval.
• Mandatory hands-on proficiency executing and verifying test scripts using electronic ALM platforms, specifically Kneat or similar tools, including electronic defect management.
• Demonstrated ability to lead cross-functional validation efforts, manage execution timelines, track overall CSV performance, and maintain strategic alignment with engineering and project management teams.

Preferred

• Experience with DeltaV DCS strategy definition, remediation, integration, and system lifecycle management activities.
• Familiarity with ISA-88 / ISA-95 standards and their application in pharmaceutical automation environments.
• Bilingual in English and Spanish (oral and written).

SKILLS

Technical Skills

• Computer System Validation (CSV) — end-to-end lifecycle management in GMP-regulated environments
• Emerson DeltaV DCS — upgrades, implementations, and lifecycle validation
• Veeva Vault QualityDocs — document control, routing, and lifecycle management
• Kneat or equivalent ALM platform — electronic test execution and defect management
• Validation documentation — Validation Plans, DSDs, RTMs, IQ/OQ protocols, Data Migration Strategies, Test Summary Reports
• cGMP, FDA 21 CFR Part 11, GAMP 5, and data integrity compliance
• Microsoft Office 365

Soft Skills

• Technical leadership — ability to drive cross-functional validation execution and maintain team accountability
• Strong communication with Engineering, Quality, and Project Management stakeholders
• Proactive risk identification and early escalation mindset throughout project lifecycle
• Detail-oriented with strong documentation discipline and audit-readiness mindset
• Adaptable and reliable in fast-paced, regulated project environments with shifting priorities