Senior Engineer Computer System Validation

Johnson & Johnson Johnson & Johnson · Pharma · Beerse, Antwerp, Belgium

This role focuses on Computer System Validation (CSV) and Data Integrity within a drug product manufacturing environment. The Senior Engineer will provide expertise on validation strategy, regulatory compliance, and data integrity, ensuring systems are fit-for-purpose, especially in evolving environments involving automation, AI, and digitalization. The role involves working with cross-functional teams, defending validation strategies during audits, and owning/improving CSV processes. While AI is mentioned as an evolving environment, the core function is validation and compliance, not direct AI/ML development.

What you'd actually do

  1. Provide expertise on computer system validation strategy, regulatory compliance, and data integrity across systems and projects.
  2. Ensure systems are validated with a fit-for-purpose approach, especially in evolving environments (automation, AI, digitalization).
  3. Work closely with the Automation team, Quality, Operations, IT and Engineering to align validation activities with business needs.
  4. Present and defend validation strategies, system status, and compliance posture during regulatory and customer audits.
  5. Own, govern and improve CSV processes, methodologies, and tools; ensure alignment with evolving regulations and internal standards.

Skills

Required

  • Master's degree or equivalent experience in Engineering or Science
  • Strong social skills and effective communication
  • Teamwork and collaboration

Nice to have

  • Experience in Computer System Validation and Data Integrity
  • Digital mindset
  • Good Automated Manufacturing Practice (GAMP)

What the JD emphasized

  • Computer System Validation
  • Data Integrity
  • regulatory compliance
  • digitalization