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Senior Expert Engineering (Capital Projects, Project Manager)

Management

Manager

No

East Hanover, New Jersey, United States

Senior Expert Engineering (Capital Projects, Project Manager)

Job ID

386337BR

Feb 01, 2024

USA

About the Role

1 purpose! Novartis expands its early development and innovative CAR-T cell therapy manufacturing capabilities in its newly launched Center of Excellence, located in the East Hanover, NJ campus. Our therapies are being developed as transformative treatments with life-saving potential for various B cell malignancies and other oncological diseases. We look to be bold with purpose, as we reimagine medicine and lead the way in advancing scientific breakthroughs for patients.

The Sr Expert Engineering (Project Manager) will report to the Associate Director of Site Engineering and Facilities Operations and will be responsible for leading the engineering effort for capital project planning, oversight and tracking at the Cell & Gene Therapy East Hanover Site in support of the overall capital portfolio. The ideal candidate will develop short- and long-range strategic plans and budgets for site development and lead CGT engineering projects while acting as the liaison to the site’s 3rd party Real estate and Facility Services IFM. They will play a critical role in evaluating and selecting engineering project partners, managing, and collaborating with internal business owners, and overseeing 3rd party contractors.

Responsibilities include, but are not limited to:

What you'll bring to the role:

• Design and implementation of facility modification (retrofits or expansions) and equipment procurement (both process and utility).

•Prepares capital investment business cases and presents to the CGT Capital Investment Governance Board and ensures critical project timelines are met.

• Prepares business continuity and contingency plans and maintains critical documentation such as the Site Master File.

• Functions as the technical lead on projects for the design, ongoing analysis, and fit-out as needed of laboratories, cell production facilities, systems, and equipment to meet federal, state and local regulations, manufacturing and quality control testing efficiency, as well as HSE and security requirements.

• Effectively manages 3rd party engineering partners in the installation, commissioning, and start-up of capital projects and works with suppliers and vendors throughout the duration of projects to obtain, review and approve proposals, work packages and contracts.

• Develops long range strategic plans for site development that further the 5-year plan.

• Develops project objectives working with system owners to establish business plans and equipment specifications, as well as standard documentation – User Requirements (URS), Functional Specification (FS), and Detail Design Specifications (DDS).

• Applies lean thinking to engineering office and laboratory processes, drives operational excellence and continuous improvement, and effectively collaborates with internal key stakeholders.

Diversity & Inclusion / EEO

We 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.

Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:

Role Requirements

What you'll bring to the role:

• B.S. degree in Chemical, Electrical or Mechanical Engineering, or equivalent related technical project experience

• 5 years of experience in pharmaceutical or biopharmaceutical based GMP manufacturing and laboratory operations. including direct experience in cell therapy processes and aseptic facilities

• Expertise understanding of GMPs and experience providing engineering team leadership and oversight in a highly regulated or pharmaceutical / biotech facility.

• Experience with capital improvement projects and processes, pharmaceutical production facilities, biotechnology laboratory process layouts, and aseptic environments

• Experience with facility and BSL2 laboratory buildout and equipment procurement, as well as the installation, commissioning and qualification of facilities, systems and equipment.

• In-depth knowledge of FDA regulations, HSE requirements, 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, as well as strong technical writing ability and computer skills required.

The pay range for this position at commencement of employment is expected to be between $118,400 and $177,600/year; 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.

Why Novartis?

236 million lives were touched by Novartis medicines in 2022, 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 [Register to View] and let us know the nature of your request and your contact information. Please include the job requisition number in your message.

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Division

Development

Business Unit

TECHNICAL R & D GDD

Location

USA

Site

East Hanover, NJ

Company / Legal Entity

Novartis Pharmaceuticals

Functional Area

Technical Operations

Job Type

Full Time

Employment Type

Regular

Shift Work

No