Website Asset Recruitment
HVAC PQ Lead
A new vacancy has arisen to join our client’s state-of-the-art biologics manufacturing facility based in Meath. This site will play an important role as the Company’s first Biologics Drug Substance single use commercialization facility. Construction is currently underway and the facility is expected to be fully operational by 2023.
The HVAC PQ Lead will perform a key management role in the start-up and operation of this Clinical to Commercial manufacturing facility. They will manage a team of Engineers, Specialists and Contracting service providers, including financial and compliance performance.
• Oversight of the HVAC Performance Qualification team, ensuring all projects are on schedule and meet the set timelines, the scope of which will include, HVAC and downflow booths
• Management of members of the team to ensure appropriate levels of training, competency and capability.
• Develop the HVAC PQ documentation and manage the execution of the HVAC PQ Plan.
• Effectively monitor and communicate the performance qualification activities and execution plan to other teams, project managers and key stakeholders.
• Lead performance qualification activities and complete all associated project documentation in line with Quality and Regulatory expectations.
• Author, review and execute performance qualification protocols for plant equipment.
• Contribute to the overall performance qualification strategy for the Bionx facility
• Maintain performance qualification documentation through the performance qualification lifecycle.
• Manage performance qualification documentation, test scripts, qualification protocols, summary reports and risk assessments.
• Participate in Quality Management Reviews as a representative of the Performance qualification team.
• Ensure compliance with environment, health and safety standards
• Ensure that all team members are suitably trained to carry out their roles effectively and assist in the co-ordination of their training programme.
• Work with the Procurement Function to hire the SME resources to execute the PQ. This includes HEPA filter integrity testing, air change rate (ACR) testing, pressure cascading, particle counting, EM (environmental monitoring)
• Level 8 qualification or equivalent in Science, Engineering or Technical
• Minimum 5 years experience in a people management leadership role
• Good Knowledge of Environmental and Safety regulatory/code requirements to Irish, European and International Codes, Standards and Practices related to Equipment and Maintenance.
• SME for HVAC equipment and processes, thorough understanding of cleanroom grades B, C and D
• Strong background in compliance documentation and CQV startup of HVAC and Cleanrooms