GxP Systems Development Engineer

Intellectt, Inc

Norwood, United States of America

1 month ago

Role details

Contract type

Permanent contract

Employment type

Full-time (> 32 hours)

Working hours

Regular working hours

Languages

English

Experience level

Intermediate

Norwood, United States of America

Program Optimization

Data Integrity

Laboratory Information Management Systems

Systems Development Life Cycle

Regression Testing

Verification and Validation (Software)

System Testing

Iq/oq/pq

Test Scripts

Information Technology

GXP

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

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