Hybrid Data Integrity Engineer - GxP & CSV Specialist

Johnson & Johnson Co.

Leiden

Hybrid

EUR 83,000 - 124,000

Full time

7 days ago
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Job summary

Johnson & Johnson is seeking a Site DI professional to lead data process flow mapping and risk assessment in a highly regulated manufacturing environment in Leiden. Hybrid work with on-site priority for critical sessions.

You will design control strategies, coordinate gap analyses, and collaborate with QA, training, and system owners to ensure data integrity and compliance with global standards. This 12-month contract offers exposure to global regulatory expectations and a challenging data

Qualifications

  • 4–6 years of pharma or life sciences experience focused on data integrity.
  • Deep knowledge of CSV and ALCOA+ principles.
  • Familiar with regulatory expectations (FDA, EMA, MHRA).
  • Ability to apply independent judgment in complex environments.

Responsibilities

  • Lead data process flow mapping sessions for equipment in manufacturing.
  • Design short and long-term control strategies for noncompliant equipment.

Skills

Data integrity
GxP compliance
CSV/ALCOA+
Regulatory knowledge
Independent judgment

Job description

Johnson & Johnson is seeking a Site DI professional to lead data process flow mapping and risk assessment in a highly regulated manufacturing environment in Leiden. Hybrid work with on-site priority for critical sessions.

You will design control strategies, coordinate gap analyses, and collaborate with QA, training, and system owners to ensure data integrity and compliance with global standards. This 12-month contract offers exposure to global regulatory expectations and a challenging data

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