LSC has an exciting opportunity for an CSV 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
If you have Experience of data analytics and reporting solutions and are ready for your next challenge, this could be the perfect project for you!
ABOUT THE PROJECT - KEY RESPONSIBILITIES:
- Manage the Computer System Validation aspect of IT projects from software install to business release
- Planning, reporting, tracking, monitoring CSV plans, documentation progress, KPI's
- Liaise with service providers and IT team to determine successful installation of software and ensure correct configuration
- Generate computer system validation documentation in accordance with site procedures and GMP guidelines
- Execute test scripts, analyse 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