CSV & Data Integrity Engineer — QA for EU CAR-T Hub

Johnson Johnson; Gent; On-site; EUR 65,000 - 90,000; Full time

Job summary

Johnson & Johnson is recruiting a QA CSV engineer and Data Integrity expert for the CAR-T hub in Europe, based in Ghent or Beerse, Belgium. This role provides quality oversight in line with Janssen policies and global cGMPs for computer system validation and data integrity in manufacturing and laboratory areas.

You will act as CSV process owner, coordinate audits, and collaborate with IT, engineering, and cross-functional teams to ensure compliance and continuous improvement in data integrity

Qualifications

• Master's degree or equivalent experience in a relevant field.
• 3 years' experience in the pharmaceutical industry.
• Knowledge of cGMP/CSV compliance (21 CFR Parts 11, 210, 211; EU Directive 2003/94/EC and annex 11; GAMP, Data Integrity Guidelines)
• Experience with Computerized System Validation.

Responsibilities

• Assure that CSV-related regulatory requirements are fulfilled across the full life cycle of computerized systems.
• Act as Process Owner for CSV management.
• Review CSV documents (SOPs, URs, risk analyses, Validation Plans, tests, changes, deviations) to maintain compliance.
• Prepare for computer system audits and inspections; be the spokesperson during audits.

Skills

CSV & cGMP

Quality Assurance

Data Integrity

English & Dutch

Education

Master's degree

Job description

Johnson & Johnson is recruiting a QA CSV engineer and Data Integrity expert for the CAR-T hub in Europe, based in Ghent or Beerse, Belgium. This role provides quality oversight in line with Janssen policies and global cGMPs for computer system validation and data integrity in manufacturing and laboratory areas.

You will act as CSV process owner, coordinate audits, and collaborate with IT, engineering, and cross-functional teams to ensure compliance and continuous improvement in data integrity