Principal/Senior Principal Engineer, Packaging (Holly Springs)

Roche•Holly Springs, NC

5d•$95,000 - $212,400•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 and cartridge filling, automated inspection, autoinjector/pen assembly, labeling and packaging. 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. The Opportunity: We're seeking a highly experienced and strategic Principal/Senior Principal Engineer to oversee the design, qualification, and operational startup of the Packaging area in our state-of-the-art manufacturing site. Your initial focus will be to provide scientific, technical, and operational leadership to establish the new Packaging operation within the Drug Product Fill and Finish facility. This involves partnering and collaborating with the Engineering Delivery team, equipment suppliers, the local User team, and Roche/Genentech network Device development and Packaging teams to establish a greenfield packaging program from the ground-up.

Requirements

Bachelor’s degree in engineering or similar
8+ years of experience (Principal) or 12+ years of experience (Senior Principal) in the pharmaceutical industry, with significant experience in packaging operations.
Recognized expert (technical and/or operational) in drug product and combination products packaging, including components, processes, and equipment.
Relevant experience in data science/engineering, analytics, and IT to drive the concept of a "smart factory."
Prior experience with technology transfers, process validation, authoring regulatory submissions, and Health Authority inspections.

Nice To Haves

Master’s, or Ph.D.
Able to organize and solve complex, unique, or unprecedented problems through ingenuity and innovation; consistently demonstrating courage and drive to ensure optimal business results.
Advanced project management skills: demonstrated ability in technology implementation and start-up.
Relevant experience coordinating with collaborators, regulatory agencies, and vendors, including advising and influencing senior management on advanced technical matters.
Strong organizational and interpersonal skills: able to get things done by optimizing results and strengthening relationships. An effective coach.
Up-to-date knowledge of cGMPs, Health Authority regulations, and Quality Systems.

Responsibilities

Collaborate closely with the Roche/Genentech network, industry experts, and technology suppliers to implement the latest, fit-for-purpose labeling and secondary packaging technology (de-traying, labeling, cartoning, case packing, palletizing, etc.).
Contribute expertise in project management, technical design, testing, qualification, recipe development, and validation to ensure the successful installation, qualification, and validation of the program.
Ensure the overall Packaging program, including operator qualification, general operating procedures, maintenance, and calibration programs, meets the latest and highest global health authority and regulatory standards for successful registration and filing.
Ensure optimum equipment selection and qualification are in place to deliver a Vertical Ramp Up with high output efficiency and minimal waste.
Be an integral part of selecting, training, qualifying, and mentoring Operators and Maintenance Technicians.
Support development of long-term training plans and provide knowledge/training on complex process and equipment technologies to all required partners. Provide training materials and act as a coach for colleagues, helping them develop skills and expertise.
Together with suppliers and contractors, build all required processes, documents, and tests to transition design plans into a functioning, approved manufacturing process.
Become the Engineering process expert for all site packaging systems.
Drive Continuous Improvement and optimization to improve quality, yield, and OEE of the assets.
Monitor and analyze machine performance, trend data, and performance parameters to predict and proactively improve the program.
Keep up to date with the latest industry changes and regulatory requirements on packaging systems to ensure site compliance—presenting the site program to Health Authorities as needed.
Own the equipment knowledge library and change management.
Manage New Product Introductions into the operation.
Foster a positive safety culture and ensure the integration of environmental health, safety, and security into the business and manufacturing processes.
Understand the bigger picture of the project, large-volume low-cost manufacturing within the CVRM disease area, and how Pharma Technical (PT) contributes to it.