Process Engineer II

Responsibilities:

• Ensuring new equipment is appropriately designed/qualified and existing processes runs in a compliant manner through equipment lifecycle.
• Owns and manages changes to the process equipment to maintain equipment in a validated state. Potentially take on a global role in ensuring consistency across manufacturing sites.
• Investigating any equipment or process deviations and developing corrective actions to prevent reoccurrences.
• Participate in all FDA and internal audits of the manufacturing facilities and process equipment as SME and respond to any observations received.
• Actively monitor equipment performance in compliance with site reliability and maintenance strategies. Applies knowledge of engineering principles and best practices to ensure robust solutions.
• Provide mentorship to other process engineers.
• Assist to provide SME support on capital related projects. Establish equipment specifications in standard documentation – User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS).
• Help evaluate new technologies and equipment platforms for manufacturing.
• Providing engineering, validation and maintenance support to the process manufacturing equipment, facility and utilities at a site. Equipment may include major processing equipment such as bioreactors, tangential flow filtration, chromatography, filling equipment, support systems such as incubators, freezers bio-safety cabinets, offline bench-top instruments or facility/utility systems.
• Assists with the translation of current and future processes into the facility and utility equipment requirements at a manufacturing site.

Requirements:

• B.S. degree in Chemical, Electrical or Mechanical Engineering, or related technical field, with 2 years work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations; OR 6 years equivalent work experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations.
• Excellent oral and technical writing and communication skills.
• Experience working in a team environment, with good organizational skills.
• Experience in development, automation, and manufacture of gene therapy products, medical devices, instruments OR biotechnology.
• Strong foundation FDA regulations and GMP systems and experience providing engineering support in a highly regulated or pharmaceutical / biotech facility.
• Developing professional expertise, applies company policies and procedures with ability to work on problems of moderate scope where analysis of situations or data.
• Exercises judgment within defined procedures and practices to determine appropriate action and builds productive internal/external working relationships.

Why Novartis: Our purpose is to reimagine medicine to improve and extend people’s lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this? With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here:

https://www.novartis.com/about/strategy/people-and-culture.

The pay range for this position at commencement of employment is expected to be between $80,000 and $120,000 annual; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors. You can find everything you need to know about our benefits and rewards in the Novartis Life

Handbook. https://www.novartis.com/careers/benefits-rewards