Commissioning and Qualification Expert

Band

Job Description Summary

Job Description

Location:

• This position will be located in Morrisville, 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.

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.

Key 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.
• Oversee qualification deviations, investigations, and CAPAs to ensure timely and compliant resolution.
• 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.
• Monitor and report KPIs related to qualification status, deviations, CAPAs, compliance, and project performance.

Essential 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.
• Demonstrated experience leading and influencing cross-functional teams, contractors, and external partners.
• Strong problem-solving skills with experience managing deviations, investigations, risk assessments, and CAPAs.
• Fluent English communication skills with the ability to effectively engage technical and business stakeholders.

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.

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, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

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 in order to perform the essential functions of a position, please send an e-mail to tas.nacomms@novartis.com 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.

https://www.novartis.com/careers/careers-research/notice-all-applicants-us-job-openings

Salary Range

Skills Desired