GxP Operations Support Specialist, Manufacturing Systems
Core
Support the implementation, maintenance, and continuous improvement of digital manufacturing systems (MES) in a regulated pharmaceutical environment.
Role type
GxP Operations Support Specialist (Manufacturing Systems)
Builds
Digital manufacturing systems and compliant operational processes
Domain
Pharmaceutical/Biotechnology Manufacturing / GxP / Computer System Validation
Deliverable
production ML models | product features | dashboards & analysis | client delivery | infrastructure
Required skills
GxP/GMP knowledge, MES configuration, UAT execution, system documentation, incident monitoring, data analysis, process mapping, change control
Preferred skills
None stated
Technologies
MES, electronic batch records
Responsibilities
Configure, test, and deploy MES changes; support UAT including test case preparation and defect tracking; maintain SOPs, work instructions, and process maps; monitor system incidents and coordinate issue resolution; analyze production data for continuous improvement; assist with end-user training.
Seniority
Entry-level, hands-on IC
