Automation Data Integrity Lead GMP Validation & Compliance
7266-Janssen Biologics B.V. Legal Entity
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Benefits offered by this job
Job summary
Johnson & Johnson is seeking an Automation Data Integrity Lead for our Leiden site. You will strengthen quality, compliance and data integrity across automation systems, guiding validation improvements beyond individual projects and coordinating with QA Validation and system owners.
You will apply data integrity principles, risk-based thinking, and digital validation tools, including Kneat, to ensure early compliance consideration and aligned timelines.
Qualifications
- Bachelor's or master's degree in engineering, life sciences, information technology or a related field.
- Proven experience leading Data Integrity assessments, risk assessments, data process mapping and design reviews.
- Hands-on experience with electronic validation tools, Kneat preferred.
Responsibilities
- Plan and prioritize Data Integrity and validation activities across Automation per Global standards.
- Apply Data Integrity principles, risk-based thinking and validation requirements early in project planning.
- Adopt Kneat and other digital validation tools across teams.
- Coordinate data integrity assessments, risk assessments, data process mapping and design reviews.
- Maintain relationships with QA Validation, site and global Data Integrity teams to align priorities and timelines.
Skills
Education
Tools
Job description
Johnson & Johnson is seeking an Automation Data Integrity Lead for our Leiden site. You will strengthen quality, compliance and data integrity across automation systems, guiding validation improvements beyond individual projects and coordinating with QA Validation and system owners.
You will apply data integrity principles, risk-based thinking, and digital validation tools, including Kneat, to ensure early compliance consideration and aligned timelines.
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