QA CSV & Data Integrity Engineer - CAR-T European Hub

Johnson & Johnson Innovative Medicine; Beerse; On-site; EUR 60,000 - 96,000; Full time

Benefits offered by this job

Annual bonus

Vacation days

Well-being reimbursement

Insurance plans

Job summary

Johnson & Johnson Innovative Medicine is seeking a QA CSV engineer and Data Integrity expert for the CAR-T hub in Europe, based in Ghent or Beerse. You will provide quality oversight in line with Janssen policies and cGMP, focusing on computer system validation and data integrity in manufacturing and lab areas.

Responsibilities include managing CSV lifecycle, supporting audits, and collaborating with engineering and IT teams to implement compliant systems. Fluent English and Dutch are required.

Qualifications

• Master's degree in a scientific field or equivalent experience.
• At least 3 years in the pharmaceutical industry.
• Knowledge of cGMP/CSV compliance (21 CFR Part 11, 210, 211; EU Directive 2003/94/EC and annex 11).
• Experience with Computerized System Validation (CSV).
• Strong ownership and quality attitude; able to meet timelines.
• Ability to make risk-based decisions; understand business impact of quality decisions.
• Fluent in English and Dutch (spoken and written).

Responsibilities

• Ensure CSV-related regulatory requirements are met across the full life cycle of computerized systems.
• Act as Process Owner for CSV management.
• Review and approve CSV documents (SOPs, URs, risk analyses, validation plans, tests, changes, deviations).
• Maintain knowledge of international CSV regulations and apply improvements.
• Prepare for and support computer system audits and inspections.
• Be the CSV spokesperson during audits and inspections.
• Collaborate with engineering, IT and other teams for new systems and processes.
• Provide advice and support for CSV activities and ensure cGMP in new projects.
• Serve as a SME for Data Integrity topics.

Skills

CSV Validation

Data Integrity

Quality Assurance

Regulatory Knowledge

English & Dutch

Education

Master's degree or equivalent

Pharma experience 3+ years

Job description

Johnson & Johnson Innovative Medicine is seeking a QA CSV engineer and Data Integrity expert for the CAR-T hub in Europe, based in Ghent or Beerse. You will provide quality oversight in line with Janssen policies and cGMP, focusing on computer system validation and data integrity in manufacturing and lab areas.

Responsibilities include managing CSV lifecycle, supporting audits, and collaborating with engineering and IT teams to implement compliant systems. Fluent English and Dutch are required.