May 25, 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.

*This position does not have the ability to be remotely based.

The Sr Expert Engineering, will report to the Heads of Site Operations, a will be responsible for leading the engineering effort for the capital projects at the San Diego site in support of the capital portfolio. The ideal candidate will develop short and long range strategic plans and budgets for site development, and lead several engineering projects simultaneously. He/she/they will play a critical role in evaluating and selecting engineering firms, managing and collaborating with partners, and overseeing contractors.

Your responsibilities will include, but are not limited to:

• Design and implementation of facility modification (retrofits or expansions) and equipment procurement (both process and utility).
• Develops long range strategic plans for site development that further the 5-year plan.
• Functions as the technical lead on projects for design, analysis and layouts of buildings, equipment, state regulations, federal regulations, manufacturing efficiency and managing contractors (architects, HVAC, Service Engineers etc.).
• Develops project objectives working with user requirement and business plans.
• Establish equipment specifications in standard documentation – User Requirements (URS), Functional Specification (FS) and Detail Design Specifications (DDS).
• Review and approve critical documentation such as SOP’s and URS’s.
• Prepare contingency plans and logically work through complex issues
• Effectively manages 3rd party engineering partners in the installation, commissioning, and start-up of capital projects
• Work with suppliers and vendors for projects to review and receive quotes
• Apply lean thinking to engineering office processes and, drive operational excellence and continuous improvement

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
• 8 years of experience in pharmaceutical or biopharmaceutical based GMP manufacturing operations including direct experience in cell culture, recovery, purification, aseptic fill/finish
• Must have a strong understanding of GMPs and experience providing engineering team leadership and oversight in a highly regulated or pharmaceutical / biotech facility.
• Experience in the development, automation, and manufacture of gene therapy, biotech or pharmaceutical products and facilities, medical devices, instruments, or biotechnology
• Experience in process layouts, production layouts and capital improvement projects
• Experience with facility buildout and equipment procurements, installation and commissioning
• In-depth knowledge of FDA regulations and GMP systems
• Applied knowledge of Quality by Design, six sigma, and operational excellence tools in creating efficient and high-quality processes and end products
• Excellent oral and written communication skills. Strong technical writing ability required

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 (Capital Projects)

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