Operations Laboratory Systems Specialist (f/m/d)
Core
Lead projects for implementing and modifying laboratory systems, ensuring qualification, maintenance, and compliance in a regulated life sciences environment.
Role type
Senior Operations Laboratory Systems Specialist
Builds
Laboratory systems and associated processes for life sciences manufacturing
Domain
Life Sciences / Quality Control / Laboratory Information Management Systems (LIMS)
Deliverable
production ML models | product features | dashboards & analysis | infrastructure
Required skills
OT/IT knowledge, QC Systems experience, Data Integrity expertise, CFR 21 Part 11 compliance, system administration, troubleshooting, validation, change management (CRs/CAPAs), contractor supervision
Preferred skills
Experience with manufacturers and application providers, standardization of procedures, EHS and safety culture implementation
Technologies
Laboratory systems, OT/IT infrastructure, validation tools
Responsibilities
Lead implementation and modification projects for laboratory systems; Support qualification, maintenance, and upgrades; Supervise contractors and external service providers; Provide technical support and guidance to end users; Ensure Data Integrity, audit trails, and backup processes; Manage Change Requests and CAPAs; Troubleshoot system issues; Act as SME for Data Integrity and CFR 21 Part 11; Contribute to procedure standardization; Promote EHS and safety culture
Seniority
Mid-Senior, hands-on IC
