Process Engineer III

Novartis AG • Durham, NC

29d • Onsite

About The Position

As a Process Engineer III, you will provide advanced engineering expertise to ensure robust, compliant, and efficient drug product manufacturing operations. You'll lead equipment lifecycle activities-from design and qualification through validation and maintenance-while driving reliability strategies and implementing cutting-edge technologies. Your role will involve optimizing filling lines, isolators, automated inspection systems, and packaging processes, ensuring seamless integration with facility and utility systems to support global manufacturing standards.

Requirements

• 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.
• Excellent oral and written communication skills. Strong technical writing ability required.
• Working in a team environment, with excellent communication and organizational skills.
• Diverse experience in the development, automation, and manufacture of gene therapy products, medical devices, instruments, or biotechnology.
• In-depth knowledge of FDA regulations and GMP systems and experience providing engineering support in a highly regulated or pharmaceutical / biotech facility.
• Strong project management skill set with extensive experience in strategic / tactical planning, demonstrated ability to perform long-term project planning.
• Demonstrates skill in developing contingency plans and solving complex problems under pressure.

Nice To Haves

• Experience with advanced automation technologies and digital manufacturing solutions.
• Familiarity with global regulatory requirements and multi-site manufacturing environments.

Responsibilities

• Primary responsibilities for this role will be with drug product equipment and processes, to include filling lines, isolators, automated visual inspection, device assembly, and packaging.
• Ensures new equipment is appropriately designed/qualified and existing processes run in a compliant manner through equipment life cycle. Help define and optimize equipment qualification strategy.
• Owns and manages changes to process equipment to maintain validated state; may drive global consistency across sites.
• Investigates equipment or process deviations and develops corrective actions; provides expertise for complex investigations.
• Serves as SME during FDA and internal audits; responds to observations and ensures compliance.
• Develops and implements equipment reliability and maintenance strategies that are compliant, effective, and cost-appropriate.
• Provides mentorship to process engineers and leads small teams to optimize systems and processes, including creating User Requirements Specifications (URS), Functional Specifications (FS), and Detailed Design Specifications (DDS).
• Leads or supports capital projects and establishes equipment specifications.
• Evaluates new product introductions and facility fit; advances facility and equipment changes aligned with strategic plans.
• Assesses and introduces new technologies and equipment platforms to enhance manufacturing capabilities.

Benefits

• 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Industry: Chemical Manufacturing
• Number of Employees: 5,001-10,000 employees