Senior Temperature Mapping Validation Engineer

Job Summary: 

The Senior Temperature Mapping Validation Engineer will be accountable for planning, executing, analyzing, and documenting temperature mapping activities across critical and Controlled Temperature Units (CTUs) at the Alexion Manufacturing Dublin facility (ADMF). This includes the qualification of fridges, freezers, incubators, cold rooms, autoclaves, and steam-in-place (SIP) cycles. 

This role will ensure Temperature Mapping qualification and requalification activities  completed comply with regulatory requirements, validation lifecycle management, internal procedures, and industry best practices. 

Key Responsibilities: 

• Lead the planning, execution, and documentation of temperature mapping and requalification studies for GMP-critical equipment.  

• Ensure compliance with validation lifecycle principles and change control processes. 

• Lead a team of technicians to ensure Validation activities are completed in a  timely manner to meet schedule. 

• Develop and approve temperature mapping protocols, plans and reports in accordance with site procedures and regulatory requirements e.g. cGMP, EU, and FDA requirements. 

• Collaborate with cross-functional teams including Quality, Engineering, Facilities, Supply Chain etc. to ensure timely completion of validation activities. 

• Support investigations and deviations related to temperature excursions or environmental monitoring. Analyse data, process trends, validation outcomes, and recommend appropriate corrective actions. 

• Participate in audits and inspections, providing subject matter expertise on temperature mapping qualification. 

You will need to have: 

• Bachelor’s degree in Engineering, Science, or related discipline. 

• Minimum 5 years of experience in temperature mapping or validation within a GMP-regulated environment.   

• Strong knowledge of temperature mapping equipment, loggers, calibration, and data analysis tools. 

• Ability to keep work pace and meet deadlines. Good organisation and planning skills. 

•  Strong knowledge of regulatory requirements (EU GMP Annex 1, Annex 15, FDA, ICH Q9/Q10). 

• Excellent communication, organizational, and project management skills. 

Preferred Skills: 

• Technical Degree in Engineering/Life Sciences or greater preferred.