IT/OT Senior Lab Specialist
Core
Lead strategy, implementation, and lifecycle management of computerized laboratory systems (IT/OT) in GMP and non-GMP environments to ensure reliability, compliance, and operational excellence for innovative medicine development.
Role type
Senior IC IT/OT Lab Specialist
Builds
Computerized laboratory instrumentation software and hardware architectures
Domain
Pharmaceutical manufacturing / Biopharmaceutical lab operations / GxP compliance
Required skills
Lab instrumentation software configuration, GMP environment system leadership, Computerized system implementation in corporate networks, FDA 21 CFR Part 11 knowledge, GxP documentation management, CAPA tracking, Vendor management, Change control procedures, Operational excellence tools
Preferred skills
Contingency planning, Complex issue resolution under pressure
Technologies
Lab instrumentation software, Corporate network environments, GxP documentation systems
Responsibilities
Lead design, configuration, installation, and maintenance of lab instrumentation/equipment software and associated hardware; Manage work order execution for lab equipment maintenance; Participate as SME in health authority and internal inspections; Track and drive completion of corrective and preventive actions (CAPA); Prepare, review, approve, and archive GxP and non-GxP instrument/equipment documentation; Lead discussions with internal business partners on priorities and timelines; Create and update procedures to drive operational efficiency and compliance; Support 24x7 site-based operations including rotating on-call responsibilities
Seniority
Senior, hands-on IC
