Automation Data Integrity Lead — Validation & Compliance

Johnson & Johnson Innovative Medicine; Leiden; Hybrid; EUR 54,000 - 85,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Job summary

Johnson & Johnson Innovative Medicine in Leiden, Netherlands seeks an Automation Data Integrity Lead to strengthen quality, compliance and data integrity across automation systems. You will lead planning, stakeholder engagement, and align with global standards to implement durable validation improvements.

You will coordinate validation activities, drive risk-based decisions, and champion adoption of Kneat and digital tools across cross-functional teams.

Qualifications

• Bachelor’s or master’s degree in engineering, life sciences, information technology or related field.
• 5+ years of experience with automation or computerized systems in a GMP-regulated environment.
• Practical experience with computerized system validation and Data Integrity incl. EU GMP Annex 11 and 21 CFR Part 11.
• Proven experience leading Data Integrity assessments, risk assessments, data process mapping and design reviews.
• Hands-on experience with electronic validation tools, preferably Kneat.

Responsibilities

• Plan and prioritize Data Integrity and validation activities across Automation per Global standards.
• Apply Data Integrity principles and validation requirements in project planning and scoping.
• Guide adoption of Kneat and other digital validation tools across teams.
• Participate in Data Integrity assessments, risk assessments, and design reviews.
• Maintain relationships with QA Validation, site and global Data Integrity, and system owners.
• Support audit readiness and coordinate inspections when needed.

Skills

Analytical Reasoning

Cross-Functional Collaboration

Project Management

Education

Bachelor's or Master’s in Engineering/Life Sciences

Tools

Kneat

Job description

Johnson & Johnson Innovative Medicine in Leiden, Netherlands seeks an Automation Data Integrity Lead to strengthen quality, compliance and data integrity across automation systems. You will lead planning, stakeholder engagement, and align with global standards to implement durable validation improvements.

You will coordinate validation activities, drive risk-based decisions, and champion adoption of Kneat and digital tools across cross-functional teams.