GMP Data Integrity Engineer | CSV & Risk Expert

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

Benefits offered by this job

Mobility allowance

8% holiday allowance

26 vacation days

Career development programs

Pension contributions

Home office allowance

High-performance laptop

SIM card for personal use

FlexAbroad: up to 45 days abroad

Freedom and responsibility

Job summary

Capgemini Engineering is seeking a Data Integrity Engineer for a client in the pharmaceutical sector in Leiden. You will optimize data storage, assess risks, and develop risk mitigation initiatives while collaborating with Capgemini colleagues and client representatives on data processes and audit trails.

The role involves creating data flow diagrams in Visio, conducting risk assessments, and ensuring GMP-compliant CSV validation practices, with opportunities for professional growth and exposure

Qualifications

• Bachelor’s or Master’s degree in a technical field relevant to pharma/biotech (e.g., Food Technology, (Bio)Process Technology, Chemistry).
• Solid understanding of GMP regulations and relevant industry standards.
• Knowledge of ALCOA+ principles.
• Hands-on experience with Computer Systems Validation (CSV) is valuable.
• Experience in preparing risk assessments and documentation.

Responsibilities

• Optimize data storage and minimize data vulnerability.
• Collaborate with Capgemini Engineering colleagues and client representatives to define data processes and audit trails.
• Create data flow diagrams based on Visio and develop risk mitigation initiatives.

Skills

GMP knowledge

ALCOA+ principles

CSV experience

Risk assessments

Education

Bachelor’s or Master’s degree in Food Technology, (Bio)Process Technology, Chemistry, or related technical field

Tools

Visio

Job description

Capgemini Engineering is seeking a Data Integrity Engineer for a client in the pharmaceutical sector in Leiden. You will optimize data storage, assess risks, and develop risk mitigation initiatives while collaborating with Capgemini colleagues and client representatives on data processes and audit trails.

The role involves creating data flow diagrams in Visio, conducting risk assessments, and ensuring GMP-compliant CSV validation practices, with opportunities for professional growth and exposure