Project Engineer Data Integrity

The Data Integrity Consultant is responsible for performing Data Integrity compliance reviews for GxP small (analytical) equipment systems and associated computerized applications used within the Manufacturing and QC departments. This includes verifying equipment interfaces and documenting any identified gaps, along with proposed remediation actions. The scope and activities are executed in accordance with predefined protocols and standardized templates.

• Perform GAP Assessments, Data Flow Mappings (digital or hybrid), Data Integrity Risk Assessments, document creation and/or updates, and document reviews.
• Verify equipment interface reliability, ensuring the completeness and accuracy of data generation and/or transfer based on the established data flow.
• Review audit trails and data traceability.
• Assess access management and user account administration.
• Evaluate electronic data management processes.
• Review IT security measures and equipment control mechanisms.

• At least 1 to 3 years of relevant experience in a highly regulated environment, preferably within the pharmaceutical industry.
• Familiarity with GxP requirements for analytical equipment used in Manufacturing and/or Quality Control environments.
• Strong knowledge of Data Integrity principles and the application of ALCOA++.
• Experience with data flows, audit trails, control mechanisms, access management for systems and applications, preferably in a highly regulated environment (e.g. pharmaceutical industry).
• Knowledge of and experience with risk management and risk-based approaches (e.g. ICH Q9).
• A high level of accuracy and attention to detail.
• Strong analytical skills.
• Ability to work independently within a structured protocol using standardized templates.
• Strong communication skills and the ability to collaborate effectively within cross-functional teams.

You will join an international and innovative work environment where safety, quality, and collaboration are at the core of everything we do. You will receive a competitive compensation package and a wide range of attractive benefits, along with ample opportunities to further develop your technical expertise and contribute to challenging projects.