QA CSV & Data Integrity Lead — Europe CAR-T Hub

Johnson & Johnson Innovation; Antwerpen; Sur place; EUR 60 000 - 96 000; Plein temps

Avantages offerts par ce poste

Annual bonus

Vacation days

Parental leave

Bereavement leave

Caregiver leave

Volunteer leave

Well-being reimbursement

Health programs

Service awards

Insurance plans

Résumé du poste

Johnson & Johnson Innovation seeks a QA CSV engineer and Data Integrity expert for the CAR-T hub in Europe. Based in Ghent or Beerse, you will oversee CSV quality and data integrity in manufacturing and labs, ensuring cGMP compliance and effective audits.

You will partner with IT, engineering, and other teams to validate systems and protect data integrity while supporting multi-functional projects in a dynamic biopharma environment.

Qualifications

• Master's degree or equivalent in a scientific field or related discipline.
• 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 and regulatory audits.

Responsabilités

• Assure CSV regulatory requirements are fulfilled across the life cycle of computerized systems.
• Act as Process Owner for CSV management and document reviews (SOPs, URs, risks, validation plans, tests, changes, deviations).
• Maintain knowledge of international CSV guidelines and drive improvements.
• Prepare for computer system audits and inspections; represent CSV during audits.
• Collaborate with engineering, IT and other teams on new systems and processes.
• Provide advice on CSV activities; support cross-functional projects; be a Data Integrity SME.

Connaissances

CSV engineer

Data integrity

Quality oversight

Audits & inspections

Regulatory compliance

English & Dutch

Formation

Master's degree or equivalent

Description du poste

Johnson & Johnson Innovation seeks a QA CSV engineer and Data Integrity expert for the CAR-T hub in Europe. Based in Ghent or Beerse, you will oversee CSV quality and data integrity in manufacturing and labs, ensuring cGMP compliance and effective audits.

You will partner with IT, engineering, and other teams to validate systems and protect data integrity while supporting multi-functional projects in a dynamic biopharma environment.