New role available for an experienced CQV Engineer with a global biopharma company based in Dublin. They are currently undergoing a large expansion project whilst sustaining the manufacturing of their innovative products across the rest of the site activities.
You will be responsible for sustaining qualification activities across all manufacturing equipment as well as the support of change control and smaller on-site projects.
- Support the ongoing qualification and validation of all process equipment, facilities and utilities on site.
- Completion of periodic reviews on existing equipment.
- Actively support change controls.
- Support the management of ongoing equipment re-qualification requirements.
- Work cross functionally to develop and deliver annual equipment re-qualification requirements.
- Completes the development, review, and execution of validation plans, URSs/DQ/FATs/SATs/IQ/OQ protocols/reports.
- Ensures validation non-conformances or deviations are minimized during execution of CQV activities. For issues that do arise ensure they are closed out in a timely manner.
- Ensuring compliance with current industry regulations and guidelines relating to validation.
- Support department performance against defined KPIs.
- Participate in the control of Safety and Environmental programs. Adhere to safe working practices as set out in the Safety Statement and other company safety rules.
- Encourage actively the culture of teamwork and integration within the Engineering Services Department, and with all other Departments.
- Participate fully in cross-functional training initiatives.
- Participate in site EHS activities and ensure compliance with legislation and best practice.
- 3rd level Engineering or Science Degree, or equivalent.
- At least three years of validation experience CQV within a pharmaceutical setting.
- Knowledge of validation practices and regulatory guidelines for a pharmaceutical facility.
To learn more about this role please contact Emma Mullen - 00353 87 6369263.