Key Responsibilities: 

• 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 the process equipment to maintain equipment in a validated state. Support global initiatives ensuring consistency across manufacturing sites.
• Investigates any equipment or process deviations and developing corrective actions to prevent re-occurrences. Able to provide industry-wide expertise for complex equipment and process investigations.
• Participates in all FDA and internal audits of the manufacturing facilities and process equipment as SME and responds to any observations received. 
• Develops and implements equipment reliability and maintenance strategies that are compliant, effective and cost appropriate.
• Applies knowledge of engineering principles and best practices to ensure robust solutions.
• Provides mentorship to other process engineers.
• Leads small internal teams to help optimize engineering systems and processes.
• Independently lead or provide SME support on capital related projects.
• Establishes equipment specifications in standard documentation – User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS).

Essential Requirements:

The level of the position will be determined based on education, relevant experience, skills, and independence.

Level III Process Engineer

• 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.
• 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.

Senior Process Engineer:

• B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, with 8 years' work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations, or equivalent work experience (12 years) in pharmaceutical or biopharmaceutical based GMP manufacturing operations. 

• 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. 

AND

• 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.  

Novartis Compensation and Benefit Summary:

The salary for this position is expected to range between: Level III $89,600 and $166,400; Sr. Level $103,600 and $192,400 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.