Novartis · 19 hours ago
Process Engineer III
Durham, NC
Full-time
Onsite
Mid, Senior Level
$99K/yr - $183K/yr
5+ years expNovartis is a global healthcare company that is committed to improving patient outcomes. As a Process Engineer III, you will own the engineering and validation lifecycle for critical process manufacturing equipment, collaborating closely with Operations and Manufacturing Sciences to ensure compliance and operational effectiveness.
BiotechnologyMedical DeviceHealthcarePharmaceuticalHealth CareMedicalPrecision Medicine
No H1B
Responsibilities
Provide engineering, validation, and maintenance support to process manufacturing equipment, facilities, and utilities, including bioreactors, tangential flow filtration, chromatography, filling equipment, incubators, freezers, biosafety cabinets, bench‑top instruments, and facility or utility systems
Define, develop, and continuously improve equipment qualification and validation strategies to ensure sustained compliance across the full equipment lifecycle
Own and manage change control activities for process equipment, ensuring changes are assessed, implemented, and documented to maintain validated state
Lead complex equipment and process deviation investigations, perform root cause analysis, and implement corrective and preventive actions to prevent recurrence
Act as a subject matter expert for process equipment, facilities, and utilities during regulatory inspections and internal audits, including preparation and response to observations
Design and implement equipment reliability and maintenance strategies that balance compliance, operational effectiveness, and cost efficiency
Author and review equipment specifications and engineering documentation, including User Requirements, Functional Specifications, and Detailed Design Specifications
Independently lead or provide technical leadership on capital projects, including equipment selection, design review, installation, commissioning, and qualification
Collaborate closely with Operations and Manufacturing Sciences to assess equipment capability, facility fit, and readiness for new product introductions
Evaluate emerging manufacturing technologies and equipment platforms and contribute to long‑term facility and equipment roadmaps aligned with strategic plans
Qualification
Required
B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, with 5 years' work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations, or equivalent work experience (9 years) in pharmaceutical or biopharmaceutical based GMP manufacturing operations in lieu of a degree
Demonstrated experience providing engineering support for complex process equipment, facilities, and utilities within highly regulated manufacturing environments
In‑depth working knowledge of health authority regulations, current Good Manufacturing Practice systems, and validation expectations
Proven ability to lead technical investigations, manage change control, and develop corrective and preventive actions in response to deviations
Strong technical writing and communication skills, with experience authoring qualification, validation, and engineering documentation
Experience leading or contributing to capital projects, including equipment specification, design review, installation, commissioning, and qualification
Ability to collaborate effectively across Engineering, Operations, Quality, and Manufacturing Sciences in a fast‑paced, matrixed environment
Preferred
Experience supporting Technical Research and Development, clinical, or early‑phase manufacturing operations within pharmaceutical or biopharmaceutical environments
Demonstrated experience mentoring engineers or leading small cross‑functional technical teams across manufacturing or development sites
Benefits
Performance-based cash incentive
Eligibility to be considered for annual equity awards
Comprehensive benefits package that includes health, life and disability benefits
401(k) with company contribution and match
Generous time off package including vacation, personal days, holidays and other leaves
Company
Novartis
Novartis is a pharmaceutical company that researches and develops medicines for serious diseases to improve and extend people's lives.
10001+ employees
Funding
Current Stage
Public CompanyTotal Funding
$2.49BKey Investors
Bill & Melinda Gates Foundation
2024-06-19Post Ipo Debt· $2.49B
2018-02-14Grant· $6.5M
2000-05-19IPO
Leadership Team
Daniel Grant
Vice President & Global Program Head
John von Brachel
VP, Head of Content Lab
Recent News
2026-02-09
Company data provided by crunchbase