IT/OT Lab Specialist

 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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