Sr Validation Engineer (HVAC)

The Validation department performs equipment, utility, facility, cleaning and sterilization validation activities to ensure compliance with company procedures and industry standards in support of Operations and Quality Systems for Drug Product Manufacturing.

An exciting opportunity has opened in the validation team for a Senior Validation Engineer. In this role, you will be responsible for delivering the HVAC qualification and validation program at ADL, 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.

• 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 standards.
• Provide validation support for Company quality management system, including change control, deviation and CAPA processes.
• Coordinate projects and prioritise 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 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.
• Familiarity with Quality and Document Management Systems, including Trackwise Deviations, CAPA and Change Controls, Maximo, CDOCs and Kneat.
• Independent, self‑motivated, proactive, organised, able to multi‑task in project environments and skilled in communication and collaboration. xcfaprz
• Team player, prepared to work in and embrace a team‑based culture that relies on collaboration for effective decision‑making.