HVAC CQV Engineer

Job Summary:

We have a fantastic opportunity for a HVAC Engineer to specialized in the C&Q of cleanrooms for a 12-month contract to work for a leading pharmaceutical corporation in west Dublin. They will prepare and execute the site commissioning and validation testing for HVAC & Clean Rooms in alignment with site and global procedures.

Key Responsibilities

·      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.

·      Responsible for ensuring that all non GMP HVAC and systems are tested in compliance with project related standards from a commissioning perspective.

·      Deviation management associated with the assigned HVAC & Clean Rooms.

·      Risk Management – Identifies and categorizes CQV risks according to impact on commissioning and qualification. Generation of action plans to mitigate qualification risks.

·      Execution of FAT testing for assigned equipment.

·      Coordination with vendors & contractors during execution of Commissioning & Qualification documents.

·      Ensuring all assigned training is executed on time to meet site metrics.

Essential Requirements:

·      Minimum of a bachelor's qualification in a scientific, technical or engineering discipline along with a minimum of 3-5 years of experience within the pharmaceutical industrial ideally with familiarity with Drug Product filling line experience.

·      Demonstratable capacity to implement a project CQV strategy, effectively execute the CQV testing approach for assigned from initiation to completion.

·      CQV project lifecycle experience from end-to-end design through to C&Q and handover.

·      Understands the project management process; programming, scope development, design development, implementation, and project closeout.

·      Demonstrable experience of performing as part of diverse team of CQV professionals/ contractors to deliver on tasks safely, with 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 in startup facilities, energizing equipment, executing startup safety documents i.e LOTO, STW, PSSR, etc.

·      Solid background of document preparation, execution, and task planning on CQV projects with a demonstrated record of on time performance.

·      Excellent communication skills and the ability to influence others.

·      Demonstratable experience working in teams in a matrix environment to deliver CQV elements.

Experience with a digital validation platform, such as ValGenesis or Kneat.

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