Validation Engineer Job

Validation Engineer is needed to perform the following duties:

· Perform commissioning and qualification of laboratory equipment Refrigerators Freezers, Autoclave and Incubators and LN2 Freezers.

· Author and execute validation life cycle protocols IQ, OQ, PQ, Traceability Matrix and validation Summary report to qualify the equipment.

· Execute validation protocols for warehouses and Controlled Temperature Units (CTUs) using electronic execution systems, specifically ValGenesis.

· Utilize Ellab Temperature Data Loggers to collect and analyze temperature data for validation purposes.

· Design and perform temperature mapping studies using Kaye Validator to ensure compliance with regulatory requirements.

· Set up and configure Kaye Validator and Ellab Eval pro , perform pre- and post-calibration of thermocouples, and conduct temperature mapping on CTUs.

· Develop and maintain accurate validation documentation and records, transitioning from paper-based to electronic systems (ValGenesis)

· Collaborate with teams to ensure successful implementation of electronic validation systems, including ValGenesis, Kneat, Kaye validator and Ellab E Val pro.

· Perform calibrations for pharmaceutical equipment’s such as analytical instrument and manufacturing instruments.

Thorough understanding and familiarity with GMP regulations including 21 CFR 210 and 211, 503B, ICH guideline knowledge

Bachelor's Degree is required in Engineering Management or Mechanical Engineering.

Health/Dental Benefits, Paid Holidays, Vacations, and Sick Leave