IT/OT Lab Specialist

Role: IT/OT Lab Specialist supporting laboratory systems in a GMP pharmaceutical environment, ensuring system performance, compliance, and operational efficiency. Responsibilities: design, install, configure, and maintain laboratory instruments and software; manage system lifecycle activities including audits, change controls, and CAPAs; support FDA inspections and internal audits; collaborate with vendors and internal teams on system architecture and connectivity; drive continuous improvements in system performance and compliance. Requirements: Bachelor's in Engineering, Computer Science, or related field; 5+ years in pharma/biopharma lab operations or equivalent; experience with laboratory computerized systems in GMP settings; knowledge of FDA regulations (21 CFR Part 11) and GMP compliance; strong communication and troubleshooting skills; experience managing vendor relationships. Desirable: experience with Quality by Design, Six Sigma, investigations, and compliance activities. HighValue: laboratory systems support in GMP biopharma; regulatory compliance, GxP, validation, audit readiness; vendor coordination; Durham, NC onsite role with no relocation support.