Automation Data Integrity Lead - Validation & CSV Systems

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

Benefits offered by this job

Annual bonus

Vacation days

Parental leave

Job summary

Johnson & Johnson Leiden site seeks an Automation Data Integrity Lead to strengthen quality, compliance and data integrity across automation systems. You will guide planning, prioritization and stakeholder alignment, applying data integrity and risk-based validation principles early in delivery.

The role requires hands-on experience with computerized validation tools (Kneat), cross-functional collaboration with QA, Engineering and Operations, and strong English communication; Dutch is a plus.

Qualifications

• Bachelor's or master's degree in engineering, life sciences, information technology or a related field.
• 5+ years of experience with automation or computerized systems in GMP environments.
• Experience with computerized system validation and Data Integrity incl. EU GMP Annex 11 and 21 CFR Part 11.
• Led Data Integrity assessments, risk assessments, data process mapping and design reviews.

Responsibilities

• Plan and prioritize Data Integrity and validation process improvement activities across Automation per global standards.
• Apply Data Integrity principles and risk-based thinking in project planning and scoping.
• Guide adoption of Kneat and other digital validation tools across teams.

Skills

Data Integrity

Validation

Stakeholder management

Project planning

Cross-functional collaboration

English communication

Change management

Education

Bachelor's or Master's degree in engineering, life sciences, information technology or related field

Tools

Kneat

Job description

Johnson & Johnson Leiden site seeks an Automation Data Integrity Lead to strengthen quality, compliance and data integrity across automation systems. You will guide planning, prioritization and stakeholder alignment, applying data integrity and risk-based validation principles early in delivery.

The role requires hands-on experience with computerized validation tools (Kneat), cross-functional collaboration with QA, Engineering and Operations, and strong English communication; Dutch is a plus.