CSV Automation Lead: Validation & Compliance

Johnson & Johnson Co.; Leiden; On-site; EUR 54,000 - 85,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Well-being program

Job summary

Johnson & Johnson in Leiden, Netherlands, seeks a CSV Execution Lead to drive validation across automation, digital, and GMP-relevant systems within capital projects and daily operations. You will coordinate cross-functional teams, ensure regulatory compliance, and coach engineers.

The role emphasizes risk-based validation per GAMP 5, data integrity integration, lifecycle governance, and inspection readiness, with an emphasis on collaboration with Engineering, Quality, IT, and projects.

Qualifications

• Bachelor's or Master's degree in Engineering, Automation, Computer Science, Information Technology, Life Sciences, or related discipline.
• 5+ years of GMP-regulated pharmaceutical/biotech/medical device experience, including CSV.
• Knowledge of cGMP, GAMP 5, DI, ALCOA+, EU GMP Annex 11, 21 CFR Part 11.
• Experience with GMP-relevant systems and interfaces (DeltaV, PLC, SCADA, MES).
• Ability to develop, review and approve qualification/validation documentation.
• Proven ability to lead validation across multiple projects and coordinate stakeholders.
• Strong analytical, risk-based problem-solving, and communication skills.
• Experience coaching and developing technical team members.
• Fluent written/spoken English.

Responsibilities

• Lead CSV and qualification across full system lifecycle.
• Define risk-based validation strategies per industry standards.
• Integrate Data Integrity into CSV workflows with DI Lead.
• Support lifecycle governance for automation systems and OT cybersecurity.
• Lead change impact assessments, deviations, and CAPAs.
• Maintain inspection-ready validation documentation and liaise with inspectors.
• Manage CSV scope, estimates, resources, and workload across projects.
• Coaching validation engineers and cross-functional collaboration.

Skills

Analytical Reasoning

Artificial Intelligence

Controls Compliance

Cross-Functional Collaboration

Industry Analysis

Innovation

Lean Supply Chain Management

Machine Learning

Project Management

Prototyping

Robotic Automation

STEM Application

Scope Management

Systems Development

Technologically Savvy

Testing

Education

Bachelor's or Master's degree in Engineering/Automation/CS/IT/Life Sciences

Tools

DeltaV

PLC

SCADA

MES

Job description

Johnson & Johnson in Leiden, Netherlands, seeks a CSV Execution Lead to drive validation across automation, digital, and GMP-relevant systems within capital projects and daily operations. You will coordinate cross-functional teams, ensure regulatory compliance, and coach engineers.

The role emphasizes risk-based validation per GAMP 5, data integrity integration, lifecycle governance, and inspection readiness, with an emphasis on collaboration with Engineering, Quality, IT, and projects.