CSV Engineer

Role Summary

The Computer System Validation Engineer 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.

Role will involve:

• Experience in Emerson Syncade MES platform, Veeva Quality Docs & Kneat (hardware and software test plans, document creation and execution ) are desirable.
• 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, 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
• Driving results and achieving progress through others – contract Systems Integrator, in-house Engineering team etc.

Desired Background/Experience/Attributes:

• 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 data analytics and reporting solutions is an advantage
• 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