LSC have a great contract opportunity for a CSV Engineer to join a leading Global Pharmaceutical company based in Cork. The Cork campus has produced small molecule API for over 30 years and has built a new Biotechnology facility which will deliver the next generation of products to the global market.
If you have minimum 5 years’ experience implementing IT solutions, systems integration, support & validating IT applications and interfaces and are ready for your next challenge, this could be the perfect opportunity for you!
ABOUT THE PROJECT – KEY RESPONSIBILITIES:
o Manage the Computer System Validation aspect of IT projects from software install to business release
o Liaise with service providers and IT team to determine successful installation of software and ensure correct configuration
o Responsibility for server installations and system related activities e.g. security, admin config settings, access permissions
o Generate computer system validation documentation in accordance with site procedures and GMP guidelines
o Execute test scripts, analyze test results and determine the acceptability of results against pre-determined criteria
o Work with the business to identify and implement procedural controls to mitigate issues found during testing
ABOUT YOU – ARE YOUR SKILLS A MATCH?
o Experience of writing validation plans, requirements gathering, design documentation, system configuration, system testing and troubleshooting
o Knowledge of 21CFR Part 11 requirements, ER/ES and data integrity guidelines
o Experience of OSI PI is an advantage
o Experience of data analytics and reporting solutions is an advantage
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!
To apply, submit your CV via this advert or contact Paul O’ Driscoll at LSC on 021-4777329 if you have anymore questions about this CSV Engineer opportunity!