Senior Engineer, Compounding, Dispensing, and Powder Handling

Roche•Holly Springs, NC

1d•$78,000 - $146,000•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. Are you a problem-solver and change-agent who thrives in a Team environment, eager to tackle the most complex manufacturing challenges? If so, this is a once-in-a-lifetime opportunity to launch a state-of-the-art facility from the ground-up and 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: In this exciting role, you will be an integral member of the User Team and will provide scientific and technical impact 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. As a key member of our technical team, this role will participate and focus on 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

Bachelor’s, Master’s, or Ph.D. degree in Bio/Chemical Engineering or a related discipline
2-4 years of experience in the pharmaceutical industry
Familiarity with aseptic compounding, fluid dynamics, automated powder handling.
Ability to understand the "bigger picture" of large-volume, low-cost manufacturing and effectively partner with and influence stakeholders across the organization without formal authority.
Ability to work in an international/global environment.
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 at the project office before transition to the site offices once complete.

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 project management, technical design, testing, qualification, and validation for all activities related to the dispensing and compounding area.
Support 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.
Participate in assigned parts of the project, justifying goals to management, and working with suppliers/contractors to transition design plans into a functioning, approved manufacturing process.
Support the design and execute studies and comparability protocols to support operations and contribute directly to cGMP documentation and regulatory filings.
Foster a positive safety culture where no one gets hurt, ensuring environmental health, safety, and security are integrated into all business and manufacturing processes.