CSV Engineer

4 weeks ago

Cork, Ireland Westbourne Full time

Overview The Validation Engineer will be responsible for the validation of Lab Systems in QCL Labs and Manufacturing Operations. We are seeking an enthusiastic and experienced validation engineer to join our team on a long-term contract basis. The Validation Engineer will provide systems validation and compliance expertise for newly purchased instruments and support of existing instruments. The position will work within a collaborative Computerized Instruments 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.
Responsibilities Manage lab equipment validation projects from install to business release
Prioritize validation activities in line with the project schedule and monitor budgets
Generate computer system validation documentation in accordance with site procedures and GMP guidelines
Liaise with service providers to determine successful installation of instrument software and ensure correct configuration
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
Follow all relevant Environmental, Health and Safety procedures and assist in incident investigations as required
Qualifications / Desired Background Minimum 3 years’ experience supporting and validating lab equipment, updating documentation, system testing, troubleshooting
Experience of analyzing and challenging software to identify gaps
Knowledge of 21 CFR Part 11 requirements, ER/ES and data integrity guidelines is desirable
Strong oral and written communication skills, 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 you come in contact, both within and outside of the laboratory area
Employment type Full-time
Seniority level Mid-Senior level
Job function Engineering and Information Technology

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