QA CSV & Data Integrity Engineer – EU CAR-T Hub

7555-Janssen Pharmaceutica NV Legal Entity; Oost-Vlaanderen; Sur place; EUR 60 000 - 96 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days and parental leave

Well-being programs

Résumé du poste

Johnson & Johnson Innovative Medicine is recruiting a QA CSV engineer and Data Integrity expert for the CAR‑T hub in Europe, based in Ghent or Beerse, Belgium. You will ensure CSV lifecycle compliance, review validation docs, and prepare for audits.

Fluent English and Dutch are required; 3 years in pharma plus CGMP/CSV knowledge are essential to drive quality across cross‑functional teams.

Qualifications

• Education: Master scientific degree or equivalent experience.
• 3 years’ experience in the pharmaceutical industry.
• Knowledge of cGMP/CSV compliance and related guidelines.
• Experience with Computerized System Validation.
• Fluent English and Dutch communication.

Responsabilités

• Ensure CSV regulatory requirements across full lifecycle.
• Act as Process Owner for CSV management.
• Review CSV documents to maintain compliance.
• Maintain knowledge of CSV regulations and industry trends.
• Prepare for audits and inspections; be a spokesperson.
• Collaborate with engineering and IT on new systems.

Connaissances

Quality Management

Regulatory Knowledge

CSV Compliance

Data Integrity

Audits

Problem Solving

Process Orientation

Quality Standards

Continuous Improvement

GMP

Team Collaboration

Risk Management

Formation

Master's degree or equivalent

Description du poste

Johnson & Johnson Innovative Medicine is recruiting a QA CSV engineer and Data Integrity expert for the CAR‑T hub in Europe, based in Ghent or Beerse, Belgium. You will ensure CSV lifecycle compliance, review validation docs, and prepare for audits.

Fluent English and Dutch are required; 3 years in pharma plus CGMP/CSV knowledge are essential to drive quality across cross‑functional teams.