Automation CSV Engineer

Johnson & Johnson seeks an Automation Data Integrity Lead for its Leiden site to strengthen quality, compliance, and data integrity across automation systems and processes. The role involves planning and prioritizing improvement activities, guiding adoption of validation tools, and building stakeholder support for new standards aligned with global GMP requirements.

Responsibilities

• Plan and prioritize Data Integrity and validation process improvements according to J&J Global standards
• Apply Data Integrity principles and validation requirements during project planning to ensure early compliance consideration
• Guide adoption and consistent application of Kneat and other digital validation tools across teams
• Conduct Data Integrity assessments, data process mapping, risk assessments, and design reviews with coordinated follow-up
• Manage relationships with Quality Assurance, site and global Data Integrity teams, and system owners to ensure alignment

Requirements

• Bachelor's or master's degree in engineering, life sciences, information technology, or related field
• 5+ years hands-on experience with automation or computerized systems in GMP-regulated environment
• Practical experience with computerized system validation, EU GMP Annex 11, and 21 CFR Part 11
• Proven experience leading Data Integrity assessments, risk assessments, and design reviews
• Hands-on experience with electronic validation tools, preferably Kneat
• Proven ability to plan cross-functional work, track progress, and escalate risks early
• Strong stakeholder management and communication skills in English; Dutch is advantageous

Compensation: €53,500–€85,445 base; €53,500–€74,300 for Netherlands location