Novartis

Novartis

Commissioning and Qualification Expert

Durham · Contract

No sponsorshipDetected 66 days ago
Project ManagementGMPLeadershipCommunicationProblem SolvingMentoringGxP

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40Risky
Cap-exempt (no lottery)0
Sponsors this role90
Entry-level history0
PERM / green-card track0
Lottery odds40
Fits your clock70

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Employer immigration record

from this employer's Department of Labor filings

Files H-1B transfers

1 transfer filing in the last year, covering 1 worker. Median labor-condition decision: 7 days. An employer that already files transfers is one that can take over an existing H-1B.

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About the role

  • Shift: Shift schedule will be phased in as the site approaches go-live.
  • We are planning for 12-hour rotating shifts which will include at least one weekend day.

Responsibilities

  • Lead C&Q activities for GMP facilities, utilities, equipment, and systems across capital projects and operations.
  • Develop and execute qualification strategies, plans, protocols, and documentation to maintain GxP compliance.
  • Drive project risk assessments and implement effective risk mitigation strategies throughout the project lifecycle.
  • Partner with cross-functional teams to deliver projects safely, on schedule, and within quality expectations.
  • Establish, implement, and continuously improve engineering standards, SOPs, templates, and best practices.
  • Support internal audits, regulatory inspections, and PAI activities while strengthening inspection readiness.
  • Manage vendor and contractor relationships, including selection, contracting, performance monitoring, and compliance oversight.
  • Provide leadership, coaching, and technical guidance to build high-performing engineering teams.
  • We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Requirements

  • Bachelor's or Master's degree in Engineering or a related technical discipline.
  • Minimum 5 years of experience in engineering projects, C&Q, validation, or compliance within GMP environments.
  • Minimum 5 years of pharmaceutical industry experience supporting regulated manufacturing operations.
  • Strong knowledge of GMP, GxP, qualification lifecycle, validation principles, and regulatory expectations.
  • Proven project management experience delivering complex engineering projects safely and compliantly.
  • Fluent English communication skills with the ability to effectively engage technical and business stakeholders.

Compensation

  • 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.

Benefits

  • 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.
  • Learning together.

Equal opportunity

  • The Novartis Group of Companies are Equal Opportunity Employers.
  • Accessibility and reasonable accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities.
  • EEO Statement:
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This listing is sourced directly from Novartis's careers page and normalized into a canonical job model.