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Validation Engineer HVAC

4 months ago

Dublin, Dublin City, Ireland TEAM HORIZON Full time

Description

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 forward-thinking company and work in a state-of-the-art facility. Attractive rates on offer as well as flexible working opportunities.

What you will be doing:
  1. Provide technical validation support to meet site objectives, comprising of the full validation lifecycle process.
  2. Develop, review, and approve validation plans, protocols, discrepancies summary reports in the area of sterilization validation.
  3. Provide support for the aseptic process simulation program, including aseptic intervention review, protocol generation, execution, and summary report generation.
  4. Provide support for airflow visualization studies and HVAC requalification program.
  5. Provide support for the execution of cycle development, performance qualifications, and requalification program in line with projects and site validation master plans.
  6. Collate and report on relevant validation data and metrics.
  7. 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.
  8. Provide validation support for the quality management system, including change control, deviation, and CAPA processes.
  9. Coordinate projects and prioritize workload in line with site priorities.
  10. Participate, when required, as a member of multidisciplinary site and multisite teams, e.g. cross-functional investigation teams and change control.
  11. Update and maintain validation Standard Operating Procedures (SOPs) in accordance with site and corporate requirements.
  12. Participate in regulatory inspections, regulatory filings.
  13. Attend and contribute to staff meetings and attend appropriate training sessions, as required.
  14. Comply with the responsibilities as outlined in the Site Safety Statement and champion safe working practices and initiatives within their functional area.
  15. 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 E.

Experience qualifying sterilization 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.


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