We are seeking an experienced CQV Engineer to support a HVAC requalification project at our clients biopharmaceutical facility in Athlone. The successful candidate will play a key role in ensuring that the HVAC systems meet all regulatory, quality, and operational requirements.
Key Responsibilities:
- Develop and execute HVAC requalification protocols (IQ, OQ, PQ) in compliance with GMP and industry regulations.
- Conduct risk assessments and impact assessments related to HVAC systems.
- Coordinate with engineering, quality, and production teams to ensure minimal disruption to ongoing operations.
- Perform data analysis, trend evaluations, and troubleshooting related to HVAC performance.
- Ensure all qualification documentation is audit-ready and meets regulatory standards (FDA, EMA, HPRA, etc.).
- Support change control activities, deviation investigations, and CAPA implementation.
- Work closely with third-party vendors and contractors for testing and maintenance activities.
- Provide technical expertise on HVAC system performance and regulatory compliance.
Requirements:
- Bachelor's degree in Engineering (Mechanical, Chemical, or related field) or equivalent experience.
- Minimum of 5 years of CQV experience in a GMP-regulated environment, preferably in biopharmaceuticals.
- Strong knowledge of HVAC systems, cleanroom classifications, and regulatory standards (ISO 14644, EU GMP Annex 1, ASHRAE, etc.).
- Experience in writing and executing IQ/OQ/PQ protocols.
- Familiarity with thermal mapping, airflow visualization, and particulate monitoring.
- Excellent problem-solving skills and the ability to analyze complex data.
- Strong communication and project coordination skills.
Preferred Qualifications:
- Experience working in biopharmaceutical or sterile manufacturing environments.
- Knowledge of building management systems (BMS) and environmental monitoring systems.
- Familiarity with LEAN, Six Sigma, or continuous improvement methodologies.
