Senior Engineer, Compounding, Dispensing, and Powder Handling

About the role

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. 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.

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.

Requirements

• You hold a Bachelor’s, Master’s, or Ph.D. degree in Bio/Chemical Engineering or a related discipline, with 2-4 years of experience in the pharmaceutical industry.
• You are familiar with aseptic compounding, fluid dynamics, automated powder handling.
• You understand the "bigger picture" of large-volume, low-cost manufacturing and can effectively partner with and influence stakeholders across the organization without formal authority.
• You foster a positive safety culture where no one gets hurt, ensuring environmental health, safety, and security are integrated into all business and manufacturing processes.

Preferred

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

Skills

• Technical acumen
• Safety & Hazard Mitigation
• Cross-Functional Collaboration
• Process Design & Scalability
• Project Execution
• Regulatory Submission

Benefits

The expected salary range for this position in Holly Springs, NC is $78,000 - $146,000. Actual pay will be determined based on experience, level, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. Relocation benefits are provided.

Pay

$78,000 - $146,000

Schedule

Full-time