IT Computer Systems 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

The IT Computer Systems Compliance Engineer will be responsible for on-going IT application and compliance support within the IT Team. They will need to have experience in implementing and supporting IT applications, technical writing, and document management in a regulated environment.

The IT Computer Systems Compliance Engineer will need to have a strong quality background to maintain quality standards in a GMP environment.

The position will work within a collaborative IT team and will be required to have excellent Communication/interpersonal skills with the ability to work on their own initiative.

Compliance experience in the areas of Data Privacy, Data Integrity and Information Security for computer systems is desirable.

Experience of working in a pharmaceutical API manufacturing operation is desirable

Experience:

• Minimum 3-5 years’ experience implementing and supporting IT applications in a GMP environment
• Experience in product life cycles from requirements through design, testing and delivery of the system into production
• Good knowledge of cGMP required to understand the quality systems on site
• Background in software development, systems analysis/configuration and Computer System Validation documentation
• Strong oral and written communication skills are required, with proven ability to communicate and build relationships cross-functionally.
• Experience implementing changes for IT applications in a GMP environment
• Attention to detail and accuracy
• Ability to meet deadlines

Role will Involve:

• Modify and Review existing CSV & Compliance documentation (e.g. Standard Operating Procedures, templates, strategy documents) focusing on continuous improvement and following up on gaps or discrepancies
• Privacy, Data Integrity and System Audit trail assessments for IT systems
• Introduction of new IT systems
• Perform Security Reviews and Periodic Reviews for IT systems
• Work directly with System Administrators/Subject Matter Experts and Quality Assurance Representatives ensuring ongoing compliance with Lilly Quality Standards and Practices
• Communicate with stakeholders to understand and clarify software requirements
• Support of Sharepoint and IT applications
• Execute test scripts, analyze test results and determine the acceptability of results against pre-determined criteria
• Work with the business to identify and implement procedural controls to mitigate issues found during testing
• Lead procedural improvements that will increase efficiency and consistency of the validation process
• Maintain tracking system for compliance actions and provide bi-weekly updates
• Generate computer system validation documentation in accordance with site procedures and GMP guidelines