CSV C&Q Technical Lead

Technical Engineering Consulting; Carolina (PR); On-site; USD 90,000 - 150,000; Full time

Job summary

Technical & Engineering Consulting LLC seeks an Automation / CSV C&Q Technical Lead to guide validation across a major pharmaceutical capital project in Puerto Rico. You will own CSV strategy, coordinate with engineering and commissioning teams, and ensure compliance from design through handover.

The role requires senior CSV expertise in FDA-regulated environments, with hands-on IQ/OQ/PQ, RTM development, and rigorous documentation.

Qualifications

• Bachelor's degree in Automation, Controls, Chemical, Electrical Eng, Computer Science or related.
• Significant CSV experience in FDA-regulated environments and capital projects.
• Experience leading CSV activities on large projects and with cross-functional teams.

Responsibilities

• Lead CSV strategy and technical direction for the project.
• Define validation requirements and oversee validation lifecycle.
• Collaborate with Process Engineering to align automation with business needs.
• Provide leadership during software development, testing, and CQV activities.
• Develop and review validation documents (Plans, URS, FDS, FS, RTM, Test Scripts).
• Oversee IQ, OQ, PQ execution and support FAT/SAT activities.
• Manage deviations, change controls, and validation records.
• Create CSV training plans and monitor milestones and deliverables.

Skills

CSV leadership

Technical leadership

Regulatory compliance

Documentation excellence

Cross-functional collaboration

Education

Bachelor's in Automation/Controls/Engineering/CS

Tools

IQ/OQ/PQ execution

RTM development

GAMP 5 knowledge

20 CFR 11 / FDA regulatory frameworks

Job description

About the Opportunity

Technical & Engineering Consulting LLC is seeking an experienced Automation / CSV C&Q Technical Lead to support one of the most important pharmaceutical capital projects in Puerto Rico.

This position is ideal for a senior Computer System Validation (CSV) professional who enjoys leading technical teams, defining validation strategies, collaborating with automation and commissioning teams, and ensuring regulatory compliance throughout the project lifecycle.

The selected consultant will serve as the primary CSV technical lead, supporting computerized systems and automation associated with manufacturing process equipment from design through commissioning, qualification, startup, and final handover.

What You'll Do

As the Automation / CSV C&Q Technical Lead, you will:

• Lead the Computer System Validation (CSV) strategy for the project.
• Define validation requirements and technical direction throughout the project lifecycle.
• Partner with Process Engineering to ensure automation solutions meet business requirements.
• Provide technical leadership during software development and testing activities.
• Collaborate closely with Design Verification, CQV, Automation Engineering, Operations, Quality, and external vendors.
• Develop and review:
  • Validation Plans
  • User Requirements
  • Functional Specifications
  • Design Specifications
  • Requirements Traceability Matrices (RTM)
  • Test Scripts
  • Validation Summary Reports
• Lead execution of IQ, OQ, and PQ protocols for automation and computerized systems.
• Support FAT and SAT activities.
• Manage deviations, investigations, change controls, and validation documentation.
• Develop CSV training plans and training matrices.
• Monitor CSV milestones, schedules, and project deliverables.
• Ensure compliance with GAMP 5, Data Integrity (ALCOA+), cGMP, and company quality procedures.
• Support system turnover to Manufacturing and Operations.

Required Qualifications

• Bachelor's Degree in Automation, Controls, Chemical Engineering, Electrical Engineering, Computer Science, or related discipline.
• Significant experience in Computer System Validation (CSV) within pharmaceutical, biotechnology, or other FDA-regulated environments.
• Experience leading CSV activities on capital projects.
• Strong understanding of:
  • GAMP 5
  • 21 CFR Part 11
  • Data Integrity (ALCOA+)
  • cGMP requirements
• Hands-on experience developing and executing:
  • IQ/OQ/PQ
  • Validation Plans
  • RTMs
  • Test Scripts
  • Validation Reports
• Experience supporting automation platforms and computerized manufacturing systems.
• Experience with technical change management and deviation management.
• Excellent technical writing and documentation skills.
• Strong communication and leadership abilities.

Preferred Qualifications

Experience with one or more of the following is highly desirable:

• Large pharmaceutical capital projects
• Automation Lead or CSV Technical Lead roles
• Manufacturing Execution Systems (MES)
• Batch reporting systems
• Data Historians
• Alarm Management
• FAT/SAT execution
• Lilly systems and quality procedures
• Regulatory inspections and FDA audits

What We're Looking For

The ideal candidate is:

• A technical leader who can influence cross-functional teams
• Highly organized and detail-oriented
• Comfortable working in a fast-paced capital project environment
• Experienced coordinating with engineering firms, automation integrators, contractors, and quality organizations
• Passionate about delivering compliant, high-quality validation documentation

Why Join Technical & Engineering Consulting?

At Technical & Engineering Consulting LLC, you'll have the opportunity to contribute to some of Puerto Rico's largest pharmaceutical manufacturing projects while working alongside industry-leading engineering and validation professionals.

We value technical excellence, integrity, collaboration, and long-term professional relationships.