CSV Engineer

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.

 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-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, both within and outside of the laboratory area

Roles and Responsibility:

• 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