IT/OT Lab Specialist

Posted 2 Days Ago
Be an Early Applicant
Durham, NC, USA
In-Office
99K-183K Annually
Senior level
Biotech • Pharmaceutical
The Role
Support design, installation, configuration, and maintenance of laboratory instruments, computerized systems, and networks in a GMP environment. Ensure system availability, manage change controls/CAPAs, support audits and FDA inspections, partner with vendors, and drive continuous improvement for compliant lab operations.
Summary Generated by Built In

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.

#LI-Onsite


 

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 [email protected] or call +1(877)395-2339 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

Skills Required

  • Bachelor's degree in Engineering, Computer Science, Information Technology, or 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
  • Experience with Quality by Design, Six Sigma, or Operational Excellence methodologies
  • Experience supporting investigations, non-conformances, and computerized system compliance activities

Novartis Compensation & Benefits Highlights

The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about Novartis and has not been reviewed or approved by Novartis.

  • Healthcare Strength Pay and benefits are described as a strong overall package, supported by medical, dental, and vision insurance alongside FSAs/HSAs and disability and life coverage. Mental-health support is reinforced through an employee assistance program with psychological support and a network of mental health first aiders.
  • Retirement Support Retirement support is positioned as a standout element, with an automatic company contribution plus dollar-for-dollar matching in the 401(k). Additional retirement funding is described through an age-based defined contribution program and access to an employee share purchase plan discount.
  • Parental & Family Support Family-related benefits are framed as robust, including a global minimum of paid parental leave for new parents following birth or adoption. Added supports include domestic partner coverage, dependent-care resources, and benefits such as adoption assistance and child/elder care options.

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The Company
HQ: Basel
110,000 Employees
Year Founded: 1996

What We Do

Novartis is an innovative medicines company. Every day, working to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.

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