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.Validation Engineer - Biotech HVAC - DublinJob Description 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.
The sterilisation team perform /validation/ re-qualification on equipment such as VHP isolators, autoclaves, CIP/SIP systems and Lyophilisers and provide validation oversight on aseptic processing simulations.This role will focus 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.
Provide technical validation support to meet site objectives, comprising of the full validation lifecycle process.Develop, review and approve validation plans, protocols, discrepancies summary reports in the area of sterilization validation.Provide support for the aseptic process simulation program, including aseptic intervention review, protocol generation, execution and summary report generation.Provide support for airflow visualisation studies and HVAC requalification program.Provide support for the execution of cycle development, performance qualifications and requalification program in line with projects and site validation masterplans.Collate and report on relevant validation data and metrics.Assist in the development and improvements of the validation lifecycle process while ensuring continued compliance to all applicable regulations and standards.
In addition, provide input and guidance into multisite and local procedural requirements.Provide validation support for site quality management system, including change control, deviation and CAPA processes.Coordinate projects and prioritize workload in line with site priorities.Participate, when required, as a member of multidisciplinary site and multisite teams, e.g.
cross functional investigation teams and change controlUpdate and maintain validation Standard Operating Procedures (SOPs) in accordance with site and corporate requirements.Participate in regulatory inspections, regulatory filingsAttend and contribute to staff meetings and attend appropriate training sessions, as required.Comply with the responsibilities as outlined in the Site Safety Statement and champion safe working practices and initiatives within their functional area.Perform all tasks with due care and attention and in accordance with Good Manufacturing Practices RequirementsBachelor of Science/Engineering degree or equivalent.Knowledge of cGMP's and other worldwide regulatory requirements.Problem solving ability and excellent oral and written communications skills3+ years' experience in a similar roleExperience 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.PackageContract role - Hourly rate €55 - €65 per hourMinimum 12 month contract
