Senior Principal Engineer, Filling

Genentech•Cary, NC

20h•Onsite

About The Position

Welcome to Holly Springs, North Carolina— home to Genentech's largest-ever investment with an ambitious goal to be a fully connected Plant of the Future. This is where next-generation technology, capability, digital connectivity and Operational Excellence converge to create the global standard for high-volume, highly-efficient Drug Product manufacturing. This will include Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products. The facility's core is defined by innovation - leveraging advanced automation, robotics, digital tools, real-time data analytics, and simple, streamlined processes to produce the highest quality medicines. This plant will not only meet today’s demand for CVRM (Cardiovascular, Renal, and Metabolism) medicines but is a strategic commitment to be scalable with this portfolio, which serves one of the largest patient populations in the world. This is a fast-paced, highly entrepreneurial environment with a high-level of accountability from the site team to launch operations in 2028. Are you a problem-solver and change agent who thrives in a High-Performing Team environment, eager to tackle the most complex manufacturing challenges? If so, this is a once-in-a-lifetime opportunity to not only launch a state-of-the-art facility from the ground-up but to shape the culture of our organization for the next generation. Join us in Holly Springs, where you won't just build a plant—you will build the future of medicine. We're seeking a highly experienced and strategic Senior Principal Engineer to oversee all process design, qualification, startup and registration of our high volume, pre-filled syringe, aseptic filling lines at our state of the art facility. In this exciting role, you will be an integral member of the User Team and will provide scientific and technical leadership for the new large volume manufacturing facility in Holly Springs. In partnership with the Engineering and the start-up project (user) team, you will partner and collaborate with our partner organizations (Engineering and MSAT, Quality, Supply Chain, Technical Development, Regulatory, CMO, Strategy) to provide expertise in project management and technical design, testing, qualification, validation, as well as all other activities related to design and start-up a new Drug Product Fill and Finish facility. This role specifically is about the design, qualification, start-up and registration of the facility’s high volume pre-filled syringe filling lines. Following go-live of the facility, you will transition into a routine position in the site and will extend into daily operation responsibilities.

Requirements

Bachelor’s degree in chemical/mechanical engineering or similar
12+ years experience in technology of pharmaceutical industry
Recognized expert (technical and/or operational) in high volume filling operations
Able to organize and solve complex, unique or unprecedented problems through the regular use of ingenuity and innovation; consistently demonstrating courage and drive to ensure optimal business results
Advanced project management skills: demonstrated ability of technology implementation and start-up
Recognized expert/recognized authority in practical and theoretical engineering of biopharmaceutical manufacturing processes
Strong organizational and interpersonal skills: can get things done in a way that optimizes results, strengthens internal and external relationships, and with consideration of resources
Up-to-date knowledge of cGMP’s, Health Authority regulations, and Quality Systems

Nice To Haves

Relevant experience in data science/engineering, analytics, IT etc. to drive the concept of smart factory is desirable
Prior experience with technology transfers, process validation, authoring regulatory submissions, and Health Authority inspections is desirable
Relevant contact with collaborators, regulatory agencies, and vendors inside and outside the company including coordination across organizational lines, including advising and influencing senior management on advanced technical matters
Utilizes an established network for technical issues within the company and the industry
Able to coach others

Responsibilities

Oversee all process design, qualification, startup and registration of high volume, pre-filled syringe, aseptic filling lines
Provide scientific and technical leadership for the new large volume manufacturing facility in Holly Springs
Partner and collaborate with partner organizations (Engineering and MSAT, Quality, Supply Chain, Technical Development, Regulatory, CMO, Strategy) to provide expertise in project management and technical design, testing, qualification, validation, as well as all other activities related to design and start-up a new Drug Product Fill and Finish facility
Support the project leadership and co-lead project teams thereby driving optimal greenfield facility and operations design towards high manufacturing efficiency and quality in line to meet product and cGMP/regulatory requirements
Champion self-initiated or assigned parts of the project within the context of project and company objectives, and justify goals towards management
Provide and realize creative ideas to drive business and project efficiency and may contain connecting manufacturing technology advances and digital transformation aspects
Build all required processes, documents, tests to transition the design plans into a functioning, approved manufacturing process
Foster a positive safety culture in which no one gets hurt and ensure the integration of environmental health, safety, and security into the business and manufacturing processes, systems, and programs while reporting safety and environmental incidents within one’s functional area
Work closely with the overall project team, the wider organisation and interdepartmental staff to meet department and company goals
Effectively partner with and influence stakeholders across the broader organization without formal authority, and drive technical decisions balancing project, product, quality/regulatory and operations views
Provide knowledge and training on complex process and equipment technologies to all required partners
Provide training materials and training for people joining the organization
Act as a coach for colleagues with less experience and help them develop skills/expertise
Design and execute studies and comparability protocols to support the required operations
Contribute to cGMP documentation and regulatory filings