• Develop and execute protocols for Commissioning & Qualification of Laboratory and Manufacturing support systems (Control temperature units) and process equipment as a part of Product Quality requirement in accordance with GXP regulations.
• Develop and execute Commissioning & Qualification protocols for HVAC and Complex Utilities.
• Develop and execute protocols for Commissioning & Qualification of Process equipment (Xuri bioreactors, CO2 incubators), Refrigerator, -20C Freezer, Cryogenic Freezers and LN2 Tanks used for Product/In-process material storage used in Biotechnology Facility.
• Perform temperature mapping and humidity monitoring using Kaye validator & Ellab Portable dataloggers (Frigo) for Manufacturing & laboratory support equipment which require temperature and humidity control.
• Develop, review and approve Validation lifecycle documentation (Qualification protocols, summary reports, requirement traceability matrix) and execute in compliance with GAMP5 regulations and 21 CFR Part 11 enforced by US FDA for controlling manufacturing process and product quality in Pharmaceutical, biomedical and healthcare industries.
• Analyze and interpret validation test data using Statistical tools like MiniTab to determine whether systems or processes have met validation criteria or to identify root causes of deviations.
• Softwares & Databases Knowledge: Kaye Validator Software, ValPro, Vaisala vertique Vlog, LIMS.

Skills Required:

• Experience working in the cGMP environment.
• Experience with Single Use Technologies.
• CAR-T Manufacturing Environment
• Excellent technical writing ability.

Education:

• Bachelor's in Engineering or related education.

All your information will be kept confidential according to EEO guidelines.