GxP Systems Development Engineer

Hiring for GxP Systems Development Engineer in Norwood, MA

Job Title: GxP Systems Development Engineer

Location: Norwood, MA

Role Overview

The GxP Systems Development Engineer supports the implementation, upgrade, and validation of laboratory informatics systems (e.g., SDMS, LIMS, ELN) in GMP-regulated environments. This role ensures system compliance, data integrity, and seamless integration with laboratory instruments.

Key Responsibilities

• Support implementation and upgrades of LogiLab SDMS, including deployment and instrument integration
• Execute validation activities (IQ/OQ/PQ), test scripts, and traceability documentation
• Collaborate with infrastructure and validation teams for system upgrades and performance
• Perform regression testing and system verification post-upgrade
• Assist with change control and maintain validation/SOP documentation
• Ensure compliance with ALCOA+ data integrity principles
• Support UAT, issue resolution, and system optimization with cross-functional teams

Required Qualifications

• Bachelor’s degree in Life Sciences, Engineering, Computer Science, or related field
• 3–6+ years of experience with lab systems (SDMS, LIMS, ELN, CDS) in GMP environments
• Knowledge of GxP frameworks (GAMP 5, 21 CFR Part 11, Annex 11)
• Experience with system validation (IQ/OQ/PQ) and change control processes
• Hands-on experience with system upgrades or migrations
• Understanding of lab instrument integration and digital workflows
• Strong attention to detail and collaboration skills