Senior Validation Engineer (HVAC)

We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Dublin. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

This role will be responsible for delivering the HVAC qualification and validation programs, working in close collaboration with Engineering and Commissioning & Qualification (C&Q) teams to support new system installations, modifications, and lifecycle requalification activities. This role may support (re)qualification of additional equipment on site as required.

Duties:

• Provide technical validation support across the full validation lifecycle, partnering with Engineering and C&Q teams to ensure HVAC systems are designed, commissioned, qualified, and maintained in a validated state.
• Develop, review, and approve validation plans, protocols, and discrepancy summary reports.
• Lead and/or support the execution of airflow visualization, filter integrity, velocity, and particle monitoring activities during commissioning, qualification, and routine requalification phases.
• Assist in the development and improvement of the validation lifecycle process while ensuring compliance with all applicable regulations and company’s standards.
• Provide validation support for company’s quality management system, including change control, deviation, and CAPA processes.
• Coordinate projects and prioritize workload in line with site priorities.
• Participate in multidisciplinary site and multisite teams, such as cross-functional investigation teams and change control teams.
• Comply with the responsibilities outlined in the Site Safety Statement and champion safe working practices.
• Perform all tasks with due care and attention in accordance with Good Manufacturing Practices and company’s requirements, policies, and procedures.

• Bachelor of Science/Engineering degree or equivalent.
• Knowledge of cGMPs and other worldwide regulatory requirements.
• Problem-solving ability and excellent oral and written communication skills.
• 5+ years’ experience in a similar role
• Experience qualifying HVAC systems & cleanrooms.
• Familiarity with Quality and Document Management Systems, including Trackwise Deviations, CAPA and Change Controls, Maximo, CDOCs, Kneat.