Senior Principal Engineer, Filling

Roche•Holly Springs, NC

18h•Onsite

About The Position

This role is for a Senior Principal Engineer at Genentech's new state-of-the-art manufacturing facility in Holly Springs, North Carolina. This facility is Genentech's largest-ever investment, aiming to be a fully connected "Plant of the Future" for high-volume, highly-efficient Drug Product manufacturing, including Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, Packaging/Finished Products. The facility will leverage advanced automation, robotics, digital tools, and real-time data analytics to produce high-quality CVRM medicines. The Senior Principal Engineer will be a key member of the User Team, providing scientific and technical leadership for the design, qualification, startup, and registration of high-volume, pre-filled syringe, aseptic filling lines. This is a fast-paced, entrepreneurial environment with a high level of accountability, aiming to launch operations in 2028. The position involves partnering with various organizations (Engineering, MSAT, Quality, Supply Chain, Technical Development, Regulatory, CMO, Strategy) to provide expertise in project management, technical design, testing, qualification, and validation for the new facility. After the facility goes live, the role will transition into routine daily operation responsibilities. The role requires full-time onsite work, initially at the Genentech project office and then at the site once buildings are complete. Travel of up to 30% is expected during the project phase. This is a unique opportunity to launch a state-of-the-art facility and shape its culture.

Requirements

Hold a Bachelor’s degree in chemical/mechanical engineering or similar.
Have 12+ years experience in technology of pharmaceutical industry.
Are a recognized expert (technical and/or operational) in high volume filling operations.
Are 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.
Have advanced project management skills: demonstrated ability of technology implementation and start-up.
Are a recognized expert/recognized authority in practical and theoretical engineering of biopharmaceutical manufacturing processes.
Have 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.
Have 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.
Have up-to-date knowledge of cGMP’s, Health Authority regulations, and Quality Systems.
Ability to work in an international/global environment.
Domestic and international travel required (up to 30% during the project phase, up to 20% after full relocation).
Will work in a clean room environment that requires gowning in the form of hospital scrubs, bunny suits, gloves, and steel toe boots.
Potential to work near hazardous materials, chemicals, and equipment as per company safety procedures and guidelines.
This role will require full onsite work, initially at the Genentech project office before transition to the site offices once complete.

Nice To Haves

Relevant experience in data science/engineering, analytics, IT etc. to drive the concept of smart factory.
Prior experience with technology transfers, process validation, authoring regulatory submissions, and Health Authority inspections.

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, potentially connecting manufacturing technology advances and digital transformation aspects.
Build all required processes, documents, tests with suppliers and contractors 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.
Report 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.