CSV QA & Data Integrity Leader

Johnson & Johnson Co.; Oost-Vlaanderen; 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 anniversary awards

Insurance plans

Résumé du poste

Johnson & Johnson in Belgium is seeking a QA CSV engineer and Data Integrity expert for the CAR-T hub in Europe. The position will be based in Ghent or Beerse, Belgium, and you will provide quality oversight in line with Janssen policies and global cGMP standards for computer system validation and data integrity in manufacturing and lab areas.

You will lead CSV lifecycle activities, audits, and cross-functional collaboration with IT and engineering to ensure compliance and continuous improvement

Qualifications

• Fluent in verbal and written English and Dutch.
• Strong ownership and quality attitude with timely delivery.
• Ability to make risk-based decisions.

Responsabilités

• To assure that all Computer Systems Validation related regulatory requirements are fulfilled during the complete life cycle of computerized systems.
• Act as Process Owner for Computer Systems Validation management.
• Review and approve CSV documents such as SOPs, user requirements, risks analysis, Validation Plans, tests, changes, deviations to maintain compliance.
• Maintain knowledge of international laws and guidelines related to CSV; apply to improve CSV.
• Prepare for computer system audits and inspections.
• Be the spokesperson for CSV related matters during audits and inspections.
• Perform and follow up on internal and external audits to accomplish regulatory compliance.
• Cooperate with engineering, IT and other teams for introduction of new systems and processes.
• Be a SME for Data integrity topics.

Connaissances

Fluent English & Dutch communication

Ownership & quality mindset

Risk-based decision making

Team collaboration

Formation

Master scientific degree or equivalent

3 years' pharmaceutical industry experience

Description du poste

Johnson & Johnson in Belgium is seeking a QA CSV engineer and Data Integrity expert for the CAR-T hub in Europe. The position will be based in Ghent or Beerse, Belgium, and you will provide quality oversight in line with Janssen policies and global cGMP standards for computer system validation and data integrity in manufacturing and lab areas.

You will lead CSV lifecycle activities, audits, and cross-functional collaboration with IT and engineering to ensure compliance and continuous improvement