At the Biologics manufacturing site of Johnson & Johnson Innovative Medicine in Leiden, we are expanding our active Data Integrity team. Driven by the upcoming revisions to EU GMP Annex 11 regulations, our site is taking a proactive approach rather than waiting, reinforcing our on-site capacity and long-term compliance.
As a QC|QA Data Integrity Engineer, you will act as a Subject Matter Expert (SME) at the intersection of process automation and Computer System Validation (CSV), with a dedicated focus on safeguarding data integrity. This is strictly not a traditional, desk-bound Quality Assurance role that merely audits documentation. We are seeking a professional with deep technical affinity and genuine shop-floor knowledge who can act as an authoritative technical peer to system owners, automation specialists, and QA.
Your daily responsibilities are structured around two primary pillars:
Remediation of Operational Systems:
... - Close identified gaps across existing manufacturing and laboratory systems to achieve full, sustainable compliance.
- Remediate findings related to user access management, audit trails, and backup & restore procedures.
- Design both pragmatic short-term control strategies and structural long-term solutions aligned with business operations and Quality & Compliance.
Integration and Qualification of New Equipment:
- Autonomously prepare and validate Data Process Flow Mappings (D | PFM) for the continuous stream of incoming manufacturing and analytical equipment.
- Facilitate and lead data risk assessments with Technical and Business System Owners, including compiling and securing timely cross-functional approvals for risk assessment reports.
Guidance and Procedural Improvements:
- Enhance the procedural framework surrounding Data Integrity topics and guide system owners to meet evolving regulatory expectations.
- Bridge the gap between abstract regulatory requirements and workable, hands-on shop-floor operations.
