Validation Engineer HVAC

Team Horizon is seeking a Validation Engineer with HVAC qualification experience on a contract basis for a leading biotechnology company based in Dublin.

Why you should apply:

• This is an excellent opportunity to join a forwrad thinking company and work in a state of the art facility.


• Attractive rates on offer aswell as flexible working opportunities

What you will be doing:

• 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 company standards. In addition, provide input and guidance into multisite and local procedural requirements.


• 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, when required, as a member of multidisciplinary site and multisite teams, e.g. cross functional investigation teams and change control


• Update and maintain validation Standard Operating Procedures (SOPs) in accordance with site and corporate requirements.


• Participate in regulatory inspections, regulatory filings


• Attend 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 and company requirements, policies and procedures

What you need to apply:

• 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. o     


• 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.