About the role
Within our client's production departments, raw materials are transformed into filled medicines. The product goes through several manufacturing steps (weighing, formulation, preparation, lyophilization, filling, capping, inspection, storage, and transport). At every stage, production strives for the highest level of operational excellence.
AS HVAC Validation Analyst, you will work within the Utilities Department. The HVAC Validation team is responsible for the timely execution of validation activities for equipment and rooms related to product storage (refrigerators, freezers, climate chambers, warehouses, freeze dryers, incubators, etc.), as well as the validation of the cooling and ventilation systems (HVAC) themselves.
Key responsibilities
- Independently plan, monitor, and execute routine validation programs for validation studies of equipment, HEPA filters, laboratory and production devices, and temperature-controlled areas within the site.
- Prepare validation worksheets and ensure their approval and classification according to the appropriate procedures.
- Enter and manage all validation data in the dedicated validation software.
- Initiate and follow up on quality deviations; report deviations observed during validation studies.
- Collaborate and coordinate with various departments
- Ensure the continuous availability of validation equipment.
- Monitor and correctly process validations carried out by external companies.