Cork  

JOB DESCRIPTION

SimoTech require a CSV Engineer for a Pharmaceutical site based in Cork. The selected candidate will be responsible for the Computer System Validation of IT solutions being implemented for a continuous manufacturing facility. The CSV Engineer 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.

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.
• 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.

Qualifications

• 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.

What SimoTech Can Offer

• 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 capital projects.

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