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# Data Integrity Engineer

- **Company:** J&J
- **Location:** Leiden, Netherlands (Remote available)
- **Experience:** Experienced
- **Contract:** Temporary contract
- **Skills:** Audit Trail, Business Systems, Data Integrity, Electronic Signatures, Data Streaming, System Testing, Computerised Systems, GXP
- **Published:** October 21, 2026
- **Apply:** https://www.indeed.com/viewjob?jk=bfbd12a2fa72746a

## About the Role

* Strong, up-to-date knowledge of computerised systems, data integrity principles, and GxP compliance, including current regulatory expectations (e.g., FDA, EMA, MHRA guidance).
 * Understands both technical and procedural requirements of Data Integrity in manufacturing and analytical environment
 * Proven ability to apply independent judgment and decision-making to develop sound solutions that balance structural, regulatory, and business needs.
 * 4-6 years of experience in the pharmaceutical or life sciences industry, with a focus on data integrity, quality systems, or validation.
 * Hands-on experience with global, complex, and highly regulated environments, preferably in a multinational organisation.
 * Familiarity with risk-based approaches, audit trail reviews, and electronic record/electronic signature compliance.
 * Strong understanding of CSV (Computer System Validation) and ALCOA+ principles.
 * Decisive, pragmatic and persevering with a can-do mentality.

## Description

* As part of a Site DI project core team member, lead and facilitate data process flow mapping (D/PFM) sessions for equipment located in the manufacturing area (analytical, manufacturing, execution systems) followed by data risk assessment meetings with stakeholders such as business & technical system owners.
 * Key role in designing short control strategies and long-term plans for any noncompliant equipment which can be accepted by the business and the quality & compliance unit
 * Create the data risk assessment reports and coordinate the timely review & approval of the reports
 * Performs and analyses data integrity gap assessments and proposes remediations (technical, procedural, training), coordinating activities and stakeholders to lead to full gap remediation.
 * Collaborate with Business System Owners, Technical System Owners, QA and Training to identify the most efficient action to be taken for any system and at any step of the data flow
 * Analyses data integrity gaps and leads activities toward remediation
 * Improves the procedural framework related to DI topics
 * Guides Business System Owners and Technical System Owners in meeting current and preparing for future expectation of Data Integrity
 * Manages work according to a schedule