IT/OT Lab Specialist

Novartis • Durham, NC

6h • Onsite

About The Position

Imagine being the technology partner who keeps critical laboratory operations running smoothly, compliantly, and efficiently every day. As an IT/OT Lab Specialist at Novartis, you will play a key role in supporting the computerized systems and laboratory technologies that enable scientific innovation and operational excellence. You'll work alongside cross-functional teams to ensure reliable system performance, maintain compliance with regulatory requirements, and help deliver the technology foundation that supports our mission to reimagine medicine for patients worldwide.

Requirements

• Bachelor's degree in Engineering, Computer Science, Information Technology, or a related technical field.
• 5+ years of pharmaceutical or biopharmaceutical laboratory operations experience, or equivalent industry experience.
• Experience installing, configuring, and maintaining laboratory computerized systems in a GMP environment.
• Experience implementing computerized systems within a corporate network infrastructure.
• Knowledge of FDA regulations, including 21 CFR Part 11, and other applicable GMP requirements.
• Strong written and verbal communication skills with the ability to collaborate across diverse teams.
• Experience managing vendor relationships and supporting third-party service providers.
• Proven troubleshooting and problem-solving abilities in complex, regulated operational environments.

Nice To Haves

• Experience with Quality by Design, Six Sigma, or Operational Excellence methodologies.
• Experience supporting investigations, non-conformances, and computerized system compliance activities.

Responsibilities

• Support the design, installation, configuration, and maintenance of laboratory instruments, software, and associated hardware.
• Ensure high availability and reliable performance of laboratory computerized systems and equipment.
• Partner with vendors and internal stakeholders to implement effective system architectures and connectivity solutions.
• Execute maintenance activities, user reviews, audit trail reviews, and other system lifecycle requirements.
• Manage change controls, CAPAs, and system documentation in accordance with GxP requirements.
• Support FDA inspections, internal audits, and compliance activities across assigned laboratory areas.
• Drive continuous improvement initiatives that enhance operational efficiency, compliance, and system performance.

Benefits

• health, life and disability benefits
• a 401(k) with company contribution and match
• a variety of other benefits
• generous time off package including vacation, personal days, holidays and other leaves

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level