IT Computer Systems Compliance Engineer

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

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