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Skills: Laboratory operations, GMP, 21 CFR Part 11, System lifecycle management, Audit trail review
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Sign up with Clera and we'll reach out the moment a role actually fits you — no more spraying applications into the void.
$99k–$183k/yr
Full-time
bachelor degree
Health benefits, Life insurance, Disability benefits, 401(k) with company contribution and match, Performance-based cash incentive, Annual equity awards
Posted 4d ago
~40 hrs/week
Responsibilities
The IT/OT Lab Specialist will support the design, installation, and maintenance of laboratory instruments and computerized systems to ensure operational excellence. They will also manage system documentation, audit trails, and compliance activities in accordance with GxP and FDA requirements.
Requirements
Candidates must hold a bachelor's degree in a technical field and possess at least 5 years of experience in pharmaceutical or biopharmaceutical laboratory operations. Proficiency in GMP environments, FDA regulations, and computerized system infrastructure is essential for this role.
Full 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 us.reasonableaccommodations@novartis.com 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.
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.
Find out more at https://www.novartis.com
See our community guidelines: https://go.novartis.social/3Nboxki
Offices: Novartis Campus, Basel, Baselstadt 4002, CH · One Health Plaza, East Hanover, NJ 07936, US · Calle 93B S-31, Bogota, Bogota, D.C. 110541, CO · Merrion Road, Dublin, County Dublin, IE · Na Pankraci 1724/129, Prague, Prague 140 00, CZ
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