GxP Systems Development Engineer
Job Description
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