Validation Engineer

1 week ago


Old Toronto, Ontario, Canada JobContax Full time

Validation Engineer - Biotech HVAC - Dublin

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 gain experience at Ireland's leading aseptic manufacturing plant.

  1. Deliver on the qualification and validation program, including planning and execution of sterilization validation/requalification activities on critical sterilization/decontamination equipment such as VHP isolators, autoclaves, CIP/SIP systems, and Lyophilizers.
  2. Focus on HVAC requalification in the production environments, managing routine re-qualification programs of airflow visualization and filter integrity testing activities.
  3. Provide technical validation support for the full validation lifecycle process, including developing, reviewing, and approving validation plans, protocols, and discrepancies summary reports in the area of sterilization validation.
  4. Support the aseptic process simulation program, airflow visualization studies, and HVAC requalification program.
  5. Assist in the execution of cycle development, performance qualifications, and requalification programs in line with projects and site validation master plans.
  6. Collate and report relevant validation data and metrics, providing support for the site quality management system and coordinating projects in line with site priorities.
  7. Participate in multidisciplinary site and multisite teams, update and maintain validation Standard Operating Procedures, and participate in regulatory inspections and filings.
  8. Comply with the responsibilities outlined in the Site Safety Statement, champion safe working practices and initiatives, and perform all tasks with due care and attention.

Requirements:

  • Bachelor of Science/Engineering degree or equivalent.
  • Knowledge of cGMPs and other worldwide regulatory requirements.
  • Problem-solving ability, excellent oral and written communication skills.
  • 3+ years of experience in a similar role, including experience in equipment qualification and the validation lifecycle process in line with ASTM E2500.
  • Experience in qualifying sterilization equipment, isolators, HVAC systems, and/or providing validation support for aseptic process simulation.
  • Experience with 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, 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

If you have the relevant experience, please forward your CV to for review or call to discuss in confidence.


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