Ireland Job Openings
Alexion Pharmaceuticals,Inc.
Senior HVAC Qualification Engineer
Dublin
November 29, 2024
The Senior HVAC Qualification Engineer is responsible for reviewing design of the HVAC system and ensuring it remains within its validated state. In addition, they are also responsible for generating qualification protocols, protocol execution, field verification and generation of summary reports. This individual will be required to work in a cross functional team and independently to accomplish validation objectives. The role will include engaging in early stage of projects, providing input into design, attending FATs and design reviews ensuring validation requirements are met in line with regulatory expectations.
You will be responsible for:
- Act as Validation SME on HVAC systems.
- Commissioning and start-up of HVAC systems.
- Responsible for providing expert technical support in validation to meet the objectives of quality, output and cost in developing trouble shooting, standardising and improving new and existing equipment.
- Support regulatory inspections for queries related to HVAC qualification.
- Assure that all validation test procedures are in line with current technology, Alexion, and regulatory requirements.
- Executing protocols, troubleshooting issues, field verification and generation of summary reports.
- Lead the annual requalification program, including managing the routine program of airflow visualisation and filter integrity testing activities, as well as testing in response to changes to the production environment.
- Experience in System Startup, Commissioning, Functional Testing & qualification necessary, including safe systems of work.
- Project management of new installations, modifications, and improvements to existing systems.
- Lead troubleshooting and remediation project teams as required.
- Leading Risk assessments, root cause analysis and investigations.
- Participate in problem solving teams across all areas in Alexion
- Vendor supervision ensuring the highest standards of safety and quality are maintained.
- Proactively keeping up to date with current thinking and best practice.
- Typically, 5+ years of experience dealing with HVAC Qualification.
- Experience in HPRA/FDA environment advantageous.
- Knowledge of Annex 1 requirements, as they pertain to Drug Substance manufacturing.
- Excellent technical abilities with a solid base in engineering.
- Ability to keep work pace and meet deadlines. Good organisation and planning skills.
- Strong communication skills. Problem solver with a focus on achievement of overall project goals.
- Ability to work independently and remotely with minimum direct supervision.
- Experience in issue description, root cause identification, technical/quality impact assessment & corrective action justification.
- Experience in quality assurance environments, quality management systems and GMP change management processes and impact assessments would be an advantage.
- Must be goal-oriented and able to prioritize and manage tasks.
- Technical Degree in Engineering/Life Sciences or greater preferred.
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