Senior Principal Process Engineer, Visual Inspection (MSAT)

Genentech • Holly Springs, NC

8d • Onsite

About The Position

Genentech is seeking a Visual Inspection (VI) expert to provide end-to-end VI program leadership for a highly automated greenfield drug product manufacturing facility in Holly Springs, North Carolina. The role will develop a compliant visual inspection process from kit building and Knapp studies through high-speed automated inspection, including automated eject inspection, and all intervening steps. The engineer will work with Manufacturing, Asset Engineering, Automation, and Quality Assurance to establish the program from the ground up, then maintain and change-manage it through commercial production.

The position provides technical expertise for syringe and cartridge visual inspection, including manual, semi-automated, and automated operations. The engineer will serve as the primary VI contact for the Global MSAT network, stay current on regulatory and industry trends, contribute to validation and technology transfer, and support process optimization, troubleshooting, investigations, and continuous improvement. The Holly Springs facility is a planned 2028 launch and is described as an entrepreneurial, fast-paced environment focused on advanced automation, robotics, digital tools, real-time analytics, and operational excellence.

The role is fully onsite at the project office before transitioning to site offices. It involves working in a global environment, domestic and international travel (up to 20% after full relocation), and possible cleanroom work requiring gowning. The expected salary range for the Holly Springs, NC primary location is $114,400–$212,400. Actual pay depends on experience, level, qualifications, geographic location, and other job-related factors. A discretionary annual bonus may be available, and relocation benefits are provided. The posting says the position qualifies for benefits detailed at a linked page but does not specify the benefits.

Requirements

• Bachelor's or master's degree in Engineering, Pharmaceutical Sciences, or a related technical field.
• Eight or more 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.
• Expertise with 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, handle multiple projects, prioritize and delegate effectively, adapt quickly to change, and collaborate on cross-functional teams.
• Demonstrated project management skills.
• Ability to work fully onsite at the project office before transitioning to site offices.
• Ability to work in an international or global environment.
• Ability to travel domestically and internationally, up to 20% after full relocation.
• May work in a cleanroom environment requiring gowning in 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 end-to-end visual inspection program leadership for a highly automated greenfield facility.
• Develop a compliant visual inspection process spanning kit building and Knapp through high-speed automated inspection, including automated eject inspection.
• Work with Manufacturing, Asset Engineering, Automation, and Quality Assurance to develop the visual inspection program and maintain and change-manage it for commercial production.
• Provide technical expertise and support for syringe and cartridge visual inspection operations, including process development, optimization, troubleshooting, and improvement initiatives.
• Support manual, semi-automated, and automated drug product visual inspection operations.
• Serve as the primary point of contact for visual inspection to the Global MSAT network.
• Keep up with visual inspection regulatory and industry trends.
• Participate in process validation activities.
• Design reject material classifications, trending, and response.
• Assist the MSAT Lab with design of the particulate management program and defect libraries.
• Defend the visual inspection program in regulatory inspections, including Pre-Approval Inspections.
• Gather data, perform root cause analysis, 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 related 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, supporting successful scale-up and process validation.

Benefits

• A discretionary annual bonus may be available based on individual and Company performance.
• Relocation benefits are provided.
• The position qualifies for benefits detailed at a linked page; specific benefits are not listed in the posting.

What This Job Offers

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