Automation Data Integrity Lead (GMP & Validation)

Johnson Johnson; Leiden; Hybrid; EUR 90.000 - 130.000; Vollzeit

Zusammenfassung

Johnson & Johnson's Leiden site seeks an Automation Data Integrity Lead to strengthen data integrity across automation systems. You will lead planning, validation improvements and stakeholder engagement to ensure robust data governance and compliance with EU GMP Annex 11.

You will guide the implementation of digital validation tools like Kneat, coordinate risk assessments, and partner with QA Validation, site DI, CQ&A, and system owners to drive continuous quality improvements.

Qualifikationen

• 5+ years of hands-on automation experience in a GMP-regulated environment.
• Experience with computerized system validation and Data Integrity (EU GMP Annex 11, 21 CFR Part 11).
• Proven experience leading Data Integrity assessments, risk assessments, process mapping and design reviews.
• Hands-on experience with Kneat or other digital validation tools.
• Strong planning, milestone setting and cross-functional coordination skills.
• Excellent English communication; Dutch is a plus.

Aufgaben

• Plan and prioritize Data Integrity and validation improvements across Automation per J&J standards.
• Apply Data Integrity principles during project planning and scoping to embed compliance.
• Lead adoption of Kneat and ensure consistent use across teams.
• Coordinate Data Integrity assessments, risk mappings and design reviews with stakeholders.
• Maintain alignment with QA Validation, site DI, CQ&A and system owners.
• Support audits and inspections, including EU GMP Annex 11 topics; assist in readiness.

Kenntnisse

Automation experience

Stakeholder management

Communication skills

Cross-functional collaboration

Ausbildung

Bachelor's or master's degree in engineering, life sciences, IT or related field

Tools

Kneat

Jobbeschreibung

Johnson & Johnson's Leiden site seeks an Automation Data Integrity Lead to strengthen data integrity across automation systems. You will lead planning, validation improvements and stakeholder engagement to ensure robust data governance and compliance with EU GMP Annex 11.

You will guide the implementation of digital validation tools like Kneat, coordinate risk assessments, and partner with QA Validation, site DI, CQ&A, and system owners to drive continuous quality improvements.