Computer System Validation Engineer Job

Computer System Validation Engineer is needed to perform the following duties:

Provide software related Commissioning and qualification support for new laboratory equipment ensuring integration with lab management software.
Coordinate with IT teams for the integration of software systems with laboratory equipment ensuring proper communication and functionality.
Work with vendors to facilitate software related IQ/OQ execution managing IT tasks and additional software IQ/OQ testing when required.
Perform commissioning installation operational and performance qualification for new laboratory equipment with a focus on software configuration and integration.
Oversee software system integration and qualification activities for laboratory equipment including TOC/Conductivity meters, microplate analyzers, pH Meters, Balances, Water Baths, Osmometers, HPLCs, UV, spectrometers and Incubators.
Ensure compliance with software systems related to Good Manufacturing Practices (GMP) and Global Qualification Standards (GQS605 & GQS201).
Assist in the creation of a new Kneat workspace for equipment requiring software based qualification per GQS201 standards.
Manage qualification documentation for analytical equipment within AIQ workspace using the Kneat software system.
Maintain detailed software system documentation and ensure compliance with regulatory standards throughout the qualification process.
Troubleshoot and resolve any software related issues during the qualification process ensuring seamless integration and performance of lab equipment.
Provide training and support to end users on software systems related to laboratory equipment ensuring proper usage and adherence to compliance guidelines.
Perform other duties as assigned.

Bachelor's degree is required in Computer Science & Engineering

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