Software Configuration Engineer

Custom Software Engineer

Project Role : Custom Software Engineer
Project Role Description : Implement the configuration management plan as directed by the Configuration Lead. Assist in the design of software configuration and customization to meet the business process design and application requirements.
Must have skills : Laboratory Information and Execution Systems
Good to have skills : NA
Minimum 12 year(s) of experience is required
Educational Qualification : 15 years full time education

Summary: The Systems Engineer will serve a key role supporting the delivery and administration of laboratory systems. The individual will assist in configuration and deployment of systems, participate in generating and maintaining necessary procedure. Activities will also include authoring and executing test protocols. Roles & Responsibilities: Manage a team of engineers maintaining the laboratory systems Represent Digital GxP Lab System team in system validation activities in conjunction with IT, Validation and QA related to implementation of new lab systems and on-going support thereafter. Work independently to author System Configuration Specification, System Administration SOP, execute test scripts following cGxP. Author, review and approve lifecycle documents like Impact assessment, Regulatory applicability and criticality assessments, ERES assessments etc. Work with the Lab Automation team to interface the standalone systems with our SDMS and LIMS Provide support to the QC labs for the laboratory computer systems as system administrator. Participate in the periodic reviews of the systems used in the QC Laboratories and assist as digital administrator for the systems. Assists in evaluation or product enhancements and capabilities, implementing upgrades as required. Support initial and routine upgrade system risk assessment and testing activities Professional & Technical Skills: A bachelor s degree in STEM or another relevant academic discipline. A minimum 5-7 years of industry experience implementing and maintaining laboratory systems. Experience with Chromeleon, SDMS and LabVantage LIMS preferred. Experience authoring and reviewing computer system validation lifecycle documents. Working understanding of cGMP and manufacturing operations and practices. Strong communication skills (verbal and written). Demonstrated ability to work independently and collaboratively in cross-functional teams. Compliance focused mindset . Additional Information: - The candidate should have minimum 12 years of experience in Laboratory Information and Execution Systems. - This position is based at our Kolkata office. - A 15 years full time education is required.