Commissioning and Qualification Expert

Novartis • Durham, CA

1d • $98,700 - $183,300 • Onsite

About The Position

Imagine leading C&Q activities that ensure the safe, compliant, and efficient delivery of innovative manufacturing capabilities that help bring life-changing medicines to patients. As a Commissioning & Qualification Expert at Novartis, you will play a critical role in driving GMP and GxP compliance across capital projects and manufacturing operations. You will partner with cross-functional teams to develop qualification strategies, oversee project execution, manage risk, and strengthen inspection readiness while advancing operational excellence. This is an exciting opportunity for a technically skilled leader to influence complex projects, shape engineering standards, and make a meaningful impact on patients worldwide.

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.

Nice To Haves

• Business Continuity
• Cost Management
• Operational Excellence
• Quality Compliance

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.

Benefits

• health
• life and disability benefits
• 401(k) with company contribution and match
• generous time off package including vacation, personal days, holidays and other leaves
• performance-based cash incentive
• eligibility to be considered for annual equity awards

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level