Apr 06, 2022

Job Description

12,000. The number of associates worldwide working together to reimagine medicine!

The Global Drug Development (GDD) organization oversees the development of new medicines discovered by our researchers and partners. We transform the lives of people by developing innovative and life-changing medicines.

The Senior Expert, Engineering is responsible for providing engineering, validation and maintenance support to the process manufacturing equipment, facility and utilities at a site.

Your responsibilities will include, but are not limited to:

• Provides 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.
• 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. Potentially take on a global role in 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 leads 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).
• Works closely with operations and manufacturing sciences to evaluate new product introductions and facility fit evaluations.
• Leads small teams to define and advance facility and equipment changes in line with 5- and 10-year strategic plans.
• Leads evaluation of new technologies and equipment platforms for manufacturing.
• Translates current and future processes into the facility and equipment requirements at a manufacturing site.
• Other related job duties as assigned.

Diversity & Inclusion / EEO

The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Minimum Requirements

What You'll Bring to the Role:

• 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.
• 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.
• Ability to prepare contingency plans and logically work through complex issues in a pressure filled atmosphere.
• Demonstrated ability to lead cross functional teams across manufacturing locations in a fast pace, dynamic team setting.
• Uses professional concepts in accordance with company objectives to solve complex problems in creative and effective ways.
• Full understanding of area of specialization; resolves a wide range of issues in creative ways
• Ability to work on problems of diverse scope where analysis of data requires evaluation of identifiable factors.
• Demonstrates good judgment in selecting methods and techniques for obtaining solutions.
• Networks with senior internal and external personnel in own area of expertise.

Why Novartis?
766 million lives were touched by Novartis medicines in 2021, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Global Drug Development
San Diego, CA
Technical Operations
Full Time
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Senior Expert, Engineering - Equipment Owner

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