Validation Engineer

Author and execute validation protocols for IQ, OQ, and PQ for the equipment as well as utilities, HVAC’s and facility. Ensure that the development and maintenance process are adequate in order, for the system to meet its objective. Responsible for document preparation and execution of validation protocols for a wide range of manufacturing equipment. Review validation deliverables to assure compliance with 21 CFR Part 11 (Electronic Signatures and Records) and FDA Regulations. Qualify the equipment based on cGMP (Good Manufacturing Practices) standards. Review Laminar & Terminal HEPA filter certification performance qualification procedures. Author and executed Qualification Protocols for HVAC’s, Freezers and controlled temperature units. Assist in development of Quality Control Systems in compliance with Part 820 of CFR Part 11. Qualify parts washer by following cGMP standards and using advanced quality control techniques. Review the Installation & Operational Qualification procedure of the newly installed Air Handling Unit (AHU) and generated the final qualification reports. Qualify parts washer by following cGMP standards and using advanced quality control techniques. Conduct thermal mapping studies using Data Loggers and Kaye Validator. Work along with the production team to increase the Quality standards of the product filling line and validation related activities. Author and Initiator of Events and Quality Assurance Reports in Global Quality tracking system using Track wise. Initiate Work orders and Action Items using EAMS Minimum requirements: Bachelor’s in Pharmacy or Equivalent is required 1-5 years relevant experience Strong technical writing to develop client SOPs Excellent communication skills Excellent attention to detail, analytical and problem-solving skills Experience in writing IQ, OQ and PQ protocols Knowledge of GMPs, GDPs, GLPs