SimoTech require an enthusiastic and experienced Computer System Validation Engineer for a large scale pharmaceutical project based in Cork. Candidates will be responsible for the Computer System Validation of IT solutions being implemented for a continuous manufacturing facility.
The Computer System Validation Engineer will provide IT systems validation and compliance expertise for newly introduced IT and digital solutions.
The position will work within a collaborative team and will be required to have excellent communication/interpersonal skills with the ability to work on their own initiative.
Experience of working in a pharmaceutical API manufacturing operation or a regulated environment is desirable.
- 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.
- Initiate and implement Change Control activities in accordance with Quality Standards and Practices.
- Determine solutions or recommendations for changes and/or improvements.
- Prioritize validation activities in line with the project schedule.
- Collaborating with global IT and Quality teams.
- Following all relevant Environmental, Health and Safety procedures and assist in incident investigations as required.
- 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.
- Experience of OSI PI is an advantage.
- Experience of data analytics and reporting solutions is an advantage.
- Experience of server and workstation platforms and working in a Win 10 environment.
- Strong oral and written communication skills are required, with proven ability to communicate and build relationships cross-functionally.
- Self-motivated, detail-oriented and excellent organizational and time management skills.
- Capable of relating well to other people with whom s/he comes in contact.
- Role provides a high degree of autonomy to allow the successful candidate to reach their full potential.
- Develop new skills and enhance technical ability by working with innovative technologies in a multi-disciplined environment.
- Opportunity to work with large corporate clients on exciting projects.
- Flexible working hours and location.
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