Lab Computer System Validation Engineer
The Lab Computer System Validation Engineer will be responsible for the validation of Lab Systems in QCL Labs and Manufacturing Operations.
We are seeking an enthusiastic and experienced Lab CSV Engineer to join our team on a long-term contract basis. The Lab CSV Engineer will provide systems validation and compliance expertise for newly purchased instruments and support of existing instruments.
The position will work within a collaborative Computerised 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.
Desired Background/Experience/Attributes:
Minimum 3 years’ experience supporting and validating lab equipment, updating documentation, system testing, troubleshooting
Experience of analyzing and challenging s/w to identify gaps.
Knowledge of 21CFR Part 11 requirements, ER/ES and data integrity guidelines is desirable
Strong oral and written communication skills are required, with proven ability to communicate and build relationships cross-functionall
Self-motivated, detail-oriented and excellent organizational and time management skill
Capable of relating well to other people with whom s/he comes in contact, both within and outside of the laboratory area
Role will involve:
Manage lab equipment validation projects from software install to business release
Prioritize CSV activities in line with the project schedule and monitor budgets
Generate computer system validation documentation, e.g. Design Spec, Configuration Spec, Testing, Security Plan, Test Summary Report, in accordance with site procedures and GMP guidelines
Review of software release notes
Liaise with service providers to determine successful installation of instrument software and ensure correct configuration
- Determine any specific configurations for the software, e.g. how data is saved and named
- Understand and define user permissions
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
Produce documentation that is well written and consistent throughout the document body e.g. headings, font type, font size, paragraph spacing, text alignment, correct tense
Follow all relevant Environmental, Health and Safety procedures and assist in incident investigations as required
