Process Engineer III

Key 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.

Essential 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.  

Desirable Requirements:

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

Novartis Compensation and Benefit Summary:

The salary for this position is expected to range between $89,600 and $166,400 per year. 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.

Company will not sponsor visas for this position.