GMP IT Compliance Engineer

Cognizant; Cork; On-site; EUR 65,000 - 90,000; Full time

Job summary

Cognizant Ireland is seeking an IT Computer Systems Compliance Engineer in Cork to support IT applications within a GMP regulated environment. The role requires strong quality background and excellent communication to work with QA, IT, and manufacturing teams.

Responsibilities include updating validation documentation, conducting privacy and system integrity assessments, introducing new IT systems, and ensuring adherence to Lilly Quality Standards.

Qualifications

• Minimum 3–5 years’ experience implementing and supporting IT applications in a GMP environment.
• Background in software development, systems analysis, or CSV documentation is beneficial.
• Strong communication skills and ability to work cross-functionally with QA, IT, and manufacturing.

Responsibilities

• Modify and review CSV and compliance documentation with focus on continuous improvement.
• Perform Privacy, Data Integrity and System Audit trail assessments for IT systems.
• Introduce new IT systems and execute security reviews.
• Collaborate with System Administrators and QA to ensure ongoing Lilly Quality Standards.
• Communicate software requirements to stakeholders and support SharePoint and IT applications.
• Execute test scripts, analyze results, and verify criteria against pre-determined standards.
• Lead procedural improvements to enhance validation processes and tracking of actions.

Skills

GMP IT Experience

Quality Systems

Regulatory Knowledge

Cross-functional Collaboration

Technical Writing

Information Security

Job description

Cognizant Ireland is seeking an IT Computer Systems Compliance Engineer in Cork to support IT applications within a GMP regulated environment. The role requires strong quality background and excellent communication to work with QA, IT, and manufacturing teams.

Responsibilities include updating validation documentation, conducting privacy and system integrity assessments, introducing new IT systems, and ensuring adherence to Lilly Quality Standards.