Validation Engineer - Biotech HVAC - Dublin

Are you a Validation Engineer with 3+ years experience in equipment qualification and the validation lifecycle process in line with ASTM E2500 and qualifying sterilisation equipment, isolators, HVAC systems and/or providing validation support for aseptic process simulation?

This is a contract role based in Dun Laoghaire, Dublin. If you have the relevant experience, please forward your CV to *** for review or call 353 1 7978720 to discuss in confidence.

Our client is a leading international Biotechnology company with a state of the art aseptic manufacturing facility in Dun Laoghaire, South Dublin. The plant is one of the most dynamic in Ireland and is currently undergoing rapid expansion and capital investment. This is an excellent opportunity to get experience into Ireland's leading aseptic manufacturing plant.

In this role, you will be responsible for:

• Delivering on the qualification and validation program, which will include planning and execution of sterilisation validation / requalification activities on critical sterilisation/decontamination equipment.
• Focusing on HVAC requalification in the production environments, including managing the routine re-qualification program of airflow visualisation and filter integrity testing activities as well as testing in response to changes to the production environment.
• Providing technical validation support to meet site objectives, comprising of the full validation lifecycle process.
• Developing, reviewing and approving validation plans, protocols, discrepancies summary reports in the area of sterilization validation.
• Providing support for the aseptic process simulation program, including aseptic intervention review, protocol generation, execution and summary report generation.

Requirements:

• Bachelor of Science/Engineering degree or equivalent.
• Knowledge of cGMP's and other worldwide regulatory requirements.
• Problem solving ability and excellent oral and written communications skills.
• 3+ years' experience in a similar role.
• Experience in equipment qualification and the validation lifecycle process in line with ASTM E2500.
• Experience qualifying sterilisation equipment, isolators, HVAC systems and/or providing validation support for aseptic process simulation.
• Experience of Quality and Document Management Systems including Trackwise Deviations, CAPA and Change Controls, Maximo, CDOCs, Kneat.
• Independent, self-motivated, proactive, organized, able to multi-task in project environments and skilled in communication and collaboration.
• Team player, prepared to work in and embrace a team-based culture that relies on collaboration for effective decision-making.

Package:

• Contract role - Hourly rate €55 - €65 per hour
• Minimum 12 month contract