Senior System Specialist
Core
Provide technical support, project management, and lifecycle management for cGMP instruments and workstations in Quality Control and Manufacturing environments.
Role type
Senior System Specialist (Instrumentation & Validation)
Builds
Quality Control and Manufacturing Instrumentation Lifecycle Program
Domain
Life Sciences / Pharmaceutical Manufacturing / Quality Control
Required skills
Instrument lifecycle management, Hardware/Software installation and configuration, Validation (IQ/OQ/PQ), Troubleshooting, Documentation authoring, Project management, Data integrity assessment, System health checks, Decommissioning
Preferred skills
cGMP principles, 21 CFR Part 11, ICH Annex 11, Network technologies (VLAN, firewalls), Virtualization, Microsoft OS administration
Responsibilities
Lead and support validation/qualification/upgrade, operation, maintenance, and decommissioning projects; Author and review complex instrument documentation including validation docs and change controls; Lead resolution of moderate to high impact instrumentation issues; Provide guidance on hardware/software installation, configuration, and troubleshooting; Support network teams and initiatives.
Seniority
Senior, hands-on IC with leadership responsibilities
