IT/OT Senior Lab Specialist

Role: Senior IT/OT Lab Specialist responsible for leading the strategy, implementation, and lifecycle management of computerized laboratory systems in GMP and non-GMP environments. Objectives: ensure lab systems' reliability, compliance, and operational excellence to support pharmaceutical manufacturing and development. Responsibilities: design, configure, install, and maintain lab instrumentation/software, coordinate vendor interactions, manage maintenance work orders, lead laboratory change controls, prepare and review GxP documentation, and support inspections and audits. Additionally, support operational improvements, develop SOPs, and provide technical support for lab system issues. Requirements: B.S. in Engineering, Computer Science, IT, or related field; 8+ years (or 12+ years in lieu of degree) experience in pharmaceutical or biopharmaceutical lab operations; expertise with lab system installation, configuration, and maintenance in GMP settings; knowledge of FDA 21 CFR part 11, GMP systems, and operational excellence tools. Preferred: ability to support contingency plans, work under pressure, and possibly travel up to 10%. High-Value: focus on regulated laboratory environments, computerized systems, and compliance with industry standards. Work setup: likely on-site with potential for rotating on-call duties.