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.
#LI-Onsite
EEO Statement:
Accessibility and reasonable accommodations
Salary Range
$98,700.00 - $183,300.00
Skills Desired
Benefits
Health insurance401(k)Paid time offEquity / stock options
Additional Information
Job Description Summary
Step into a pivotal engineering role where your expertise directly shapes the future of advanced manufacturing. As a Process Engineer III, you will provide engineering, validation, and maintenance support for process manufacturing equipment, facilities, and utilities at the site. In this hands-on position, you will ensure systems operate in a compliant, reliable, and efficient manner throughout their lifecycle-helping to drive operational excellence and deliver high-quality therapies to patients.
Job Description
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.