Software Configuration Specialist

3 days ago

Kolkata, West Bengal, India beBeeConfiguration Full time ₹ 35,00,000 - ₹ 50,00,000

Job Description:

Implement configuration management plans as directed by the Configuration Lead. Assist in designing software configuration and customization to meet business process design and application requirements.

Must have skills include Laboratory Information and Execution Systems, Duck Creek Policy. Good to have skills include NA.

Minimum 7.5 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 procedures. Activities will also include authoring and executing test protocols.

Roles & Responsibilities
  • Manage a team of engineers maintaining 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 ongoing 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 standalone systems with our SDMS and LIMS
  • Provide support to the QC labs for the laboratory computer systems as system administrator
  • Participate in 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
  • Bachelor's degree in STEM or another relevant academic discipline
  • 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.

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