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:

• Ensure new equipment is appropriately designed, qualified, and maintained across the equipment lifecycle
• Own and manage equipment changes to maintain a validated and compliant state
• Investigate equipment and process deviations; implement corrective actions to prevent recurrence
• Serve as subject matter expert during audits and respond to regulatory observations
• Develop and implement compliant and effective equipment reliability and maintenance strategies
• Lead or support capital projects, providing subject matter expertise and technical guidance
• Collaborate with operations to support new product introductions and facility fit evaluations
• Establish equipment specifications including user requirements, functional, and design specifications
• Evaluate and implement new technologies and equipment platforms for manufacturing operations
• Mentor process engineers and lead small teams to optimize engineering systems and processes

Essential Requirements:

• Bachelor’s degree in Chemical, Electrical, or Mechanical Engineering or related technical field
• Minimum 5 years pharmaceutical or biopharmaceutical GMP manufacturing experience, or equivalent experience
• Strong knowledge of FDA regulations and GMP systems
• Demonstrated experience supporting engineering activities in a regulated pharmaceutical or biotechnology environment
• Proven ability to lead cross-functional teams in a fast-paced and dynamic setting
• Strong project management skills with experience in both strategic and long-term planning
• Excellent written and verbal communication skills with strong technical writing capabilities
• Ability to analyze complex issues and implement effective, compliant engineering solutions

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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Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

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