GxP Systems Development Engineer

At-a-Glance:

Are you ready to build your career by joining a certified technology solutions and compliance consulting services company. If so, our client is hiring a GxP Systems Development Engineer .

Position Type:

Contract Onsite Required:

Bachelor's degree in life sciences, engineering, computer science, or related field (or equivalent experience). 3-6+ years of experience supporting laboratory informatics systems such as LogiLab SDMS, LIMS, ELN, or CDS in GMP-regulated environments. Working knowledge of GxP validation frameworks including

GAMP 5, 21 CFR

Part 11, Annex 11, and data integrity standards. Hands-on experience supporting system upgrades, migrations, or version implementations in regulated environments. Experience contributing to validation documentation and change control processes (IQ/OQ/PQ, test scripts, traceability). Understanding of laboratory instrument integration and digital lab workflows, including hybrid or cloud-based systems. Strong attention to detail, organizational skills, and ability to collaborate across cross-functional teams in a fast-paced environment.

Responsibilities:

Support the implementation and upgrade of LogiLab SDMS including application deployment, infrastructure coordination, and instrument client updates in GMP laboratories. Execute validation activities (IQ/OQ/PQ) including protocol execution, test script development, and traceability matrix support in alignment with GxP requirements. Collaborate with Infrastructure and Validation teams to support server upgrade activities and ensure compliant system performance. Perform regression testing and system verification to confirm SDMS functionality and instrument integrations post-upgrade. Assist in change control processes, including documentation updates (SOPs, work instructions, validation deliverables, and audit-ready records). Ensure adherence to data integrity principles (ALCOA+) during system configuration, validation, and deployment activities. Partner with QC, Digital, and cross-functional stakeholders to support UAT, issue resolution, and post-deployment stabilization while identifying opportunities for system optimization. Get in

Touch:

We want to hear from you! If you think you''d be a good match, submit your resume and reach out to Komal at to learn more. #LI-VK1 #HbM6349