Ascend PM are hiring a Senior Validation Engineer to join our clients team, a multinational biopharmaceutical company based in Dublin. This is a great Contract opportunity to join a growing team. Initially 12 Month Contract with view to extend. Contact or email CV to clairebrogan@ascendpm.ie to find out more
Overview:
An exciting opportunity for a Senior Validation Engineer. In this role, you will be responsible for delivering on the qualification and validation program, which will include planning and execution of validation/requalification activities on critical equipment.
This role will focus on HVAC qualification & validation in the production environments, including managing the routine re-qualification program of airflow visualisation, filter integrity, velocity & particle monitoring testing activities as well as testing in response to changes & expansion of the production environment. This role may support (re)qualification of additional equipment on site as required (E.g. Isolators, E-Beams etc.)
The Validation department performs equipment, utility, facility, cleaning, and sterilization validation activities to ensure compliance with company procedures and industry standards in support of Operations and Quality Systems for Drug Product Manufacturing.
Key Responsibilities:
- Provide technical validation support to meet site objectives, comprising the full validation lifecycle process.
- Develop, review, and approve validation plans, protocols, and discrepancy summary reports.
- Lead the execution of airflow visualization, filter integrity, velocity, and particle monitoring testing activities.
- Lead the execution of cycle development, performance qualifications, and requalification programs for VPHP isolators
- Collate and report relevant validation data and metrics.
- Assist in the development and improvement of the validation lifecycle process while ensuring compliance with all applicable regulations and standards.
- Provide validation support for quality management system, including change control, deviation, and CAPA processes.
- Coordinate projects and prioritize workload in line with site priorities.
- Participate in multidisciplinary site and multisite teams, such as cross-functional investigation teams and change control.
- Update and maintain validation Standard Operating Procedures (SOPs) in accordance with site and corporate requirements.
- Comply with the responsibilities outlined in the Site Safety Statement and champion safe working practices.
Experience & Qualifications:
- Bachelor of Science/Engineering degree or equivalent.
- Knowledge of cGMPs and other worldwide regulatory requirements.
- Experience qualifying HVAC systems and/or executing VPHP qualifications.
- Familiarity with Quality and Document Management Systems, including Trackwise Deviations, CAPA and Change Controls, Maximo, CDOCs, Kneat.