Senior Principal Process Engineer, Visual Inspection (MSAT)

Genentech • Holly Springs, NC

9d • $114,400 - $212,400 • Onsite

About The Position

Genentech is hiring a Senior Principal Process Engineer focused on Visual Inspection (VI) for its greenfield drug product manufacturing facility in Holly Springs, North Carolina. The role provides end-to-end VI program leadership, developing a compliant process from kit building and Knapp studies through high-speed automated inspection, including automated eject inspection, and the steps in between. Working with Manufacturing, Asset Engineering, Automation, Quality Assurance, and other cross-functional partners, the engineer will establish the program from the ground up and maintain and change-manage it through commercial production.

The position provides technical expertise for syringe and cartridge visual inspection operations across manual, semi-automated, and automated processes. It includes process development, optimization, troubleshooting, improvement, validation, defect and reject-material management, regulatory support, and technology transfer. The facility is a planned high-volume manufacturing site focused on CVRM medicines, with a planned launch in 2028.

The role is fully onsite at the project office before transitioning to site offices. It may involve cleanroom work requiring gowning, and domestic and international travel of up to 20% after full relocation. Relocation benefits are provided. The expected salary range for the Holly Springs, NC primary location is $114,400–$212,400; actual pay depends on experience, level, qualifications, location, and other job-related factors. A discretionary annual bonus may be available based on individual and company performance. The position also qualifies for benefits detailed at the employer's benefits link.

Requirements

• Bachelor's or master's degree in Engineering, Pharmaceutical Sciences, or a related technical field.
• At least 8 years of experience in cGMP operations.
• Strong knowledge of cGMP regulations and quality systems, with experience in a regulated environment.
• Proven ability to implement process improvements.
• Recognized expertise in visual inspection systems, including automated, semi-automated, and manual processes in a cGMP environment.
• Proficiency in data analysis and statistical tools for process monitoring and optimization.
• Detail-oriented, with strong analytical and problem-solving skills and the ability to identify root causes and implement effective corrective actions.
• Strong written and verbal communication skills.
• Ability to work independently, challenge the status quo, manage multiple projects, prioritize and delegate effectively, adapt quickly, and collaborate on cross-functional teams.
• Demonstrated project management skills.
• Ability to work in an international or global environment.
• Ability to work fully onsite at the project office before transitioning to the site offices.
• Ability to travel domestically and internationally, up to 20% after full relocation.
• Ability to work in a cleanroom environment and wear required gowning, including hospital scrubs, bunny suits, gloves, and steel toe boots.

Nice To Haves

• Experience with qualification and validation protocols.
• Familiarity with Lean Six Sigma principles and continuous improvement methodologies.

Responsibilities

• Provide technical expertise and support for syringe and cartridge visual inspection operations, including process development, optimization, troubleshooting, and improvement initiatives.
• Provide technical support for manual, semi-automated, and automated drug product visual inspection operations.
• Serve as the primary point of contact to the Global MSAT network for visual inspection.
• Keep current with regulatory and industry trends in visual inspection.
• Participate in process validation activities.
• Design reject-material classifications, trending, and response processes.
• Assist the MSAT Lab with designing the particulate management program and defect libraries.
• Defend the overall visual inspection program during regulatory inspections, including Pre-Approval Inspections.
• Gather data, conduct root cause analyses, and trend performance to develop process-control changes for complex issues.
• Support deviation investigations and root cause analyses from product-impact and process perspectives.
• Recommend and support implementation of corrective and preventive actions.
• Participate in product complaint assessments or investigations and other post-market surveillance activities as needed.
• Use Lean Production System elements and methods to continuously improve tactical business processes and procedures.
• Participate in technology transfer from development to commercial manufacturing, ensuring successful scale-up and process validation.
• Work with Manufacturing, Asset Engineering, Automation, and Quality Assurance to develop, maintain, and change-manage the visual inspection process.

Benefits

• Relocation benefits are provided.
• A discretionary annual bonus may be available based on individual and company performance.
• The position qualifies for the benefits described at the employer's benefits link.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior