Senior Principal Engineer, Compounding, Dispensing, and Powder Handling

Roche•Holly Springs, NC

18h•Onsite

About The Position

Welcome to Holly Springs, North Carolina— home to Roche/Genentech's largest-ever investment: a $2B greenfield start-up where next-generation technology, high-performing teams and Operational Excellence converge to create the global standard for high-volume, highly-efficient Drug Product manufacturing. 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 meets today’s demand for CVRM (Cardiovascular, Renal, and Metabolism) medicines and is scalable to grow with the portfolio, which focuses on next-generation metabolic medicines specifically targeting the global obesity epidemic and Type 2 diabetes. This is a fast-paced, entrepreneurial environment with a high-level of accountability, with planned launch in 2028. 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. This role specifically focuses on the design, qualification, start-up, and registration of the facility’s Dispensing, Compounding, and Powder Handling area. Serving as a critical technical anchor for the site, this role necessitates advanced expertise in process safety and high-containment engineering to manage the hazards posed by a low-OEL material with highly sensitive flammability and electrostatic characteristics. Following the go-live of the facility, you will transition into a routine position at the site, extending into daily operational responsibilities.

Requirements

Hold a Bachelor’s, Master’s, or Ph.D. degree in Bio/Chemical Engineering or a related discipline, with 12+ years of experience in the pharmaceutical/biotech industry with 3+ years in powder handling.
Be an expert in aseptic compounding, fluid dynamics, and automated powder handling.
Possess the ability to translate material properties (MIE, PSD, Resistivity) into robust, high-volume manufacturing requirements.
Understand the "bigger picture" of large-volume, low-cost manufacturing and can effectively partner with and influence stakeholders across the organization without formal authority.
Be committed to providing knowledge and training on complex process technologies, developing training materials for new staff, and coaching colleagues with less experience.
Foster a positive safety culture where no one gets hurt, ensuring environmental health, safety, and security are integrated into all business and manufacturing processes.

Nice To Haves

Experience with "Smart Factory" concepts and digital transformation to drive business and project efficiency.
Direct experience defending process design and safety concepts during Health Authority inspections.
Advanced knowledge of global ATEX/NEC standards for hybrid mixture environments.

Responsibilities

Provide expertise in project management, technical design, testing, qualification, and validation for all activities related to the dispensing and compounding area.
Define and implement the engineering control strategy required to safely manage flammability and hybrid material risks and electrostatic hazards of the API.
Partner with Engineering, MSAT, Quality, Supply Chain, Technical Development, Regulatory, and CMO organizations to drive technical decisions that balance project, product, quality, and operations views.
Design geometrically similar compounding trains (150L and 750L) to ensure scalable mixing dynamics across a wide range of batch sizes (50L to 700L), including buffer preparation and pH-controlled compounding.
Champion assigned parts of the project, justifying goals to management, and working with suppliers/contractors to transition design plans into a functioning, approved manufacturing process.
Design and execute studies and comparability protocols to support operations and contribute directly to cGMP documentation and regulatory filings.