IT/OT Lab Specialist

Novartis Group Companies; Durham (NC); On-site; USD 99,000 - 183,000; Full time

Job summary

Novartis Group Companies is seeking an IT/OT Lab Specialist based in Durham, NC, onsite. You will support laboratory computerized systems, ensure regulatory compliance, and collaborate with cross-functional teams to sustain reliable instrument performance.

The role requires a bachelor’s degree in a technical field and 5+ years in pharma/biopharma lab operations, with GMP system experience and strong vendor management skills.

Qualifications

• Bachelor’s degree in a technical field with GMP or regulated environment experience.
• Experience with laboratory computerized systems and regulatory compliance.
• Strong communication and cross-functional collaboration skills.
• Experience with vendor relationships and third-party service providers.
• Familiarity with FDA regulations, 21 CFR Part 11.

Responsibilities

• Support design, installation, configuration, and maintenance of lab instruments, software and hardware.
• Ensure high availability and reliable performance of computerized systems.
• Collaborate with vendors and stakeholders to implement system architectures.
• Execute maintenance activities, audits, and lifecycle documentation.
• Manage change controls, CAPAs, and GMP documentation.
• Support FDA inspections and internal audits for assigned labs.
• Drive continuous improvement for efficiency, compliance, and system performance.

Skills

Automation

Automation Testing

Debugging

Programming Languages

Python

Robotics

Software Testing

Technical Support

Test Automation

Education

Bachelor's degree in Engineering, Computer Science, IT or related field

Job description

Job Description Summary

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.

Job Description

Location:

• This position will be located in Durham, NC and will be an onsite role.
• Novartis is unable to offer relocation support for this role: please only apply if this location is accessible for you.

Key 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.

Essential 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.

Desirable Requirements

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

Novartis Compensation and Benefit Summary:

The salary for this position is expected to range between $98,700 and $183,300 annually

The final salary offered is determined based on factors like, but not limited to, relevant skills and experience, and upon joining Novartis will be reviewed periodically. Novartis may change the published salary range based on company and market factors.

Your compensation will include a performance-based cash incentive and, depending on the level of the role, eligibility to be considered for annual equity awards.

US-based eligible employees will receive a comprehensive benefits package that includes health, life and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. In addition, employees are eligible for a generous time off package including vacation, personal days, holidays and other leaves.

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EEO Statement:

The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.

Accessibility and reasonable accommodations

The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to [e-mail] or call [phone] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Salary Range

$98,700.00 - $183,300.00

Skills Desired

• Automation
• Automation Testing
• Debugging
• Programming Languages
• Python (Programming Language)
• Robotics
• Software Testing
• Technical Support
• Test Automation