HVAC Engineer

Your new company

Our client is a globally recognised pharmaceutical organisation with a growing sterile manufacturing facility in Dublin. The site supports the production of critical therapies and offers the opportunity to work on large-scale commissioning, qualification and validation projects within a modern production environment.

Your new role

This is an opportunity to join a major sterile manufacturing expansion project within a highly regulated pharmaceutical environment. The role focuses on the commissioning, qualification and validation (CQV) of HVAC and Clean Room systems that are critical to the production of sterile drug products. You'll work closely with engineering teams, contractors and vendors to ensure systems are commissioned, qualified and operating in compliance with GMP, EU and FDA requirements.

• Development and execution of CQV testing documentation for HVAC & Clean Rooms for the Sterile Drug Product facility.
• Responsible for meeting key project deliverables for safety, CQV schedule management and quality of project related documentation/electronic records for HVAC & Clean Rooms assigned.
• Responsible for ensuring GMP Clean Rooms, Cold Rooms and HVAC Equipment systems are tested in compliance with good manufacturing practices, company policies and EU & FDA regulations.
• Risk Management – Identifies and categorises CQV risks according to impact on commissioning and qualification.
• Generation of action plans to mitigate qualification risks.
• Coordination with vendors & contractors during execution of Commissioning & Qualification documents.
• Execution of Environmental Monitoring Performance Qualification (EMPQ) protocols in compliance with site procedures and safety procedures for the manufacturing facility.
• Performance of sampling and liaising with the laboratory to support testing of the EMPQ samples.
• Review of laboratory data and data analysis.
• Deviation management associated with the assigned HVAC & Clean Rooms.
• Preparation of validation summary reports.

What you'll need to succeed

• Bachelor’s degree in a scientific, technical or engineering discipline.
• 3–5 years of C&Q experience to include both documentation preparation and execution.
• Demonstratable capacity to implement a project CQV strategy and effectively execute the CQV testing approach from initiation to completion.
• Demonstrable experience of performing as part of a diverse team of CQV professionals/contractors to deliver tasks safely, with a quality focus, on time and within budget.
• Experience in CQV of Drug Substance/Drug Product sterile manufacturing HVAC & Clean Rooms with integrated automation platforms.
• Experience using a digital validation execution system (e.g. Kneat or ValGenesis) is an advantage but not essential.
• Strong communication skills both written and oral.
• Strong problem-solving & analytical skills.
• Ability to work within a cross-functional team.

What you need to do now

If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.

If this job isn't quite right for you, but you are looking for a new position, please contact us for a confidential discussion about your career.