Validation Specialist Job

Validation Specialist is needed to perform the following duties:

· Prepare and execute Installation Qualification (IQ), Operational Qualification
(OQ), Performance Qualification (PQ) protocols for critical GMP equipment including cold rooms, controlled rate freezers, freezers, refrigerators, biosafety cabinets, cry pods, warehouses, incubators, particle counters, centrifuges, LN2 freezers, fillers, tube sealers and welders.
· Support periodic review / re-validation of existing equipment to maintain compliance including process equipment, instrumentation, and automation systems.
· Prepare validation master plan, validation protocol and final report in compliance with 21 CFR guidelines, regulatory specifications, and FDA requirements. Apply Good Documentation Practices (GDP) in the execution of protocols, procedures and other cGMP documents.
· Draft standard operating procedures (SOPs) and support QA audits of existing operating procedures to ensure compliance with current company regulatory requirements.
· Responsible for developing and executing on validation plans according to approved procedures.
· Document any discrepancy or deviation. Investigate the root cause and recommend/perform corrective and preventive actions (CAPA) to resolve the issue.
· Participate in and present at team meetings related to process changes, process
improvements, and decision making.
· Create, populate or maintain databases for tracking validation activities, test results, or validated systems.
· Perform temperature mapping for cold rooms, freezers, warehouses, incubators and chambers.
· Perform temperature mapping studies using Kaye validator & data loggers for manufacturing, supply chain, process science and quality control equipment.
· Involve in investigating the discrepancies / deviations, troubleshooting them and determining the solution.
· Ensure all validation and qualification activities are consistent with company validation policies, procedures, and federal regulations.

Bachelor's Degree is required in Pharmaceutical Engineering or Pharmacy or Biomedical Science or Biomedical Engineering

Health/Dental Benefits, Relocation Assistance, Offers Sponsorship for U.S. Visa