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Technical Validation Engineer

2 weeks ago

Cork, Cork, Ireland TN Ireland Full time
About the Role

The Technical Validation Engineer will be responsible for validating lab systems in QCL Labs and Manufacturing Operations.

We are seeking an experienced professional with strong technical skills to join our team on a long-term contract basis. The Technical 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
  1. Manage lab equipment validation projects from installation to business release.
  2. Prioritize validation activities in line with the project schedule and monitor budgets.
  3. Generate computer system validation documentation in accordance with site procedures and GMP guidelines.
  4. Liaise with service providers to determine successful installation of instrument software and ensure correct configuration.
  5. Execute test scripts, analyze test results and determine the acceptability of results against pre-determined criteria.
  6. Work with the business to identify and implement procedural controls to mitigate issues found during testing.
  7. Initiate and implement Change Control activities in accordance with Quality Standards and Practices.
  8. Determine solutions or recommendations for changes and/or improvements.
About Us

TN Ireland is dedicated to delivering exceptional services to our clients. We are seeking a skilled professional who can contribute to our success.