LSC has an exciting opportunity for a Computer System Validation Engineer to join a pharmaceutical company in Cork. This will be a dynamic environment that is constantly innovating, relies on cutting-edge technology to deliver life-saving medicines. You will be working in a site that supplies active ingredients through complex chemical synthesis and biotechnology manufacturing processes for a range of therapeutics. This is a chance for you to work with a global company that strives for excellence in every aspect of its operation and has a huge reputation for its diverse working culture
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Manage the Computer System Validation aspect of IT projects from software install to business release
- Liaise with service providers and IT team to determine successful installation of software and ensure correct configuration
- Responsibility for server installations and system related activities e.g., security, admin config settings, access permissions
- Generate computer system validation documentation in accordance with site procedures and GMP guidelines
- 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
ABOUT YOU - ARE YOUR SKILLS A MATCH?
- Minimum 5 years' experience implementing IT solutions, systems integration, support & validating IT applications and interfaces
- Experience of writing validation plans, requirements gathering, design documentation, system configuration, system testing and troubleshooting
- Knowledge of 21CFR Part 11 requirements, ER/ES, and data integrity guidelines
Note: Are you currently eligible to work in Ireland? As this is a contract opportunity you will need to hold a Stamp 1G/Stamp 4 visa to apply!
Call Paul O Driscoll at LSC on 021 4777 329 to discuss this new role in detail or apply directly via this advert