GMP IT Compliance Engineer: Systems & Validation

Cognizant; Ireland; On-site; EUR 70,000 - 95,000; Full time

Job summary

Cognizant in Ireland seeks an IT Computer Systems Compliance Engineer to support GMP IT applications and maintain quality systems. The role requires strong communication and cross-functional collaboration within IT and QA teams.

Key responsibilities include CSV documentation review, privacy and data integrity assessments, and introducing new IT systems while ensuring compliance with Lilly Quality Standards and Practices.

Qualifications

• Minimum 3–5 years’ experience implementing and supporting IT applications in a GMP environment.
• Experience with product life cycles from requirements through design, testing and deployment to production.
• Strong knowledge of cGMP and quality systems on site.
• Background in software development, systems analysis, configuration and CSV documentation.
• Excellent written and spoken communication with cross-functional teams.

Responsibilities

• Modify and review CSV and compliance documentation, focusing on continuous improvement and closing gaps.
• Perform privacy, data integrity and system audit trail assessments for IT systems.
• Introduce new IT systems and conduct security/periodic reviews.
• Collaborate with System Administrators and QA to ensure Lilly Quality Standards are met.
• Communicate software requirements to stakeholders and support SharePoint/IT applications.
• Execute test scripts, analyze results, and ensure acceptance criteria are met.
• Help implement procedural controls to mitigate issues found during testing.
• Lead improvements to the validation process for efficiency and consistency.
• Maintain a tracking system for compliance actions and provide updates.

Skills

GMP experience

IT application implementation

Data privacy

Data integrity

Information security

Education

Bachelor's degree in IT/Computer Science

Tools

SharePoint

Documentation management

Job description

Cognizant in Ireland seeks an IT Computer Systems Compliance Engineer to support GMP IT applications and maintain quality systems. The role requires strong communication and cross-functional collaboration within IT and QA teams.

Key responsibilities include CSV documentation review, privacy and data integrity assessments, and introducing new IT systems while ensuring compliance with Lilly Quality Standards and Practices.