Data Integrity Engineer (GMP/CSV) - Pharma Data Assurance

Capgemini; Utrecht; On-site; EUR 40,000 - 59,000; Full time

Benefits offered by this job

Mobility allowance

8% holiday allowance

26 vacation days

Home office allowance

Pension contributions

Laptop and SIM

FlexAbroad 45 days/year

Job summary

Capgemini Engineering is seeking a Data Integrity Engineer for a pharmaceutical client in Leiden to optimize data storage and minimize data vulnerability.

You will define data processes, prepare risk assessments and mitigation plans, and collaborate with Capgemini teams and client representatives on documentation.

This role emphasizes ALCOA+ and CSV expertise, with growth opportunities in a global engineering services leader.

Qualifications

• Solid understanding of GMP regulations and relevant industry standards.
• Knowledge of ALCOA+ principles.
• Hands-on experience with Computer Systems Validation (CSV).
• Experience in preparing risk assessments and documentation.

Responsibilities

• Define data processes and prepare risk assessments and risk mitigation initiatives.
• Work with production equipment and data storage systems to minimize data vulnerability.
• Prepare documentation and collaborate with Capgemini Engineering colleagues and client representatives.

Skills

GMP knowledge

ALCOA+ principles

CSV experience

Risk assessments

Education

Bachelor’s or Master’s in Food Technology, (Bio)Process Technology, Chemistry

Job description

Capgemini Engineering is seeking a Data Integrity Engineer for a pharmaceutical client in Leiden to optimize data storage and minimize data vulnerability.

You will define data processes, prepare risk assessments and mitigation plans, and collaborate with Capgemini teams and client representatives on documentation.

This role emphasizes ALCOA+ and CSV expertise, with growth opportunities in a global engineering services leader.