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.
- 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.
#J-18808-LjbffrIT/OT Senior Lab Specialist in durham at Unknown Company
This position is listed as full time and onsite.