Senior Principal Process Engineer, Visual Inspection (MSAT)

Genentech; Holly Springs (MS); On-site; USD 110,000 - 160,000; Full time

Job summary

Genentech in Holly Springs, NC, is building a state-of-the-art, highly automated visual inspection (VI) program within a new, fast-paced manufacturing facility. As a Process Engineer, you will lead end-to-end VI development from kit building to high-speed automated inspection and scale-up for commercial production.

You have 8+ years in cGMP operations, deep knowledge of VI systems (automation, semi-automated, manual) and a proven ability to drive process improvements, data analysis, and

Qualifications

• Bachelor's or Master's degree in Engineering, Pharmaceutical Sciences, or a related field.
• Strong knowledge of cGMP regulations and quality systems in a regulated environment.
• Proven ability to implement process improvements.
• Expertise with visual inspection systems (automated, semi-automated and manual) in a cGMP setting.
• Proficient in data analysis and statistical tools for process monitoring and optimization.
• Detail-oriented with strong analytical and problem-solving skills.
• Strong written and verbal communication; ability to work independently and in cross-functional teams.
• Demonstrated project management skills.

Responsibilities

• Provide technical expertise for VI operations across syringe and cartridge workflows.
• Support drug product manual, semi-automated, and automated inspection operations.
• Act as primary contact to Global MSAT network for VI.
• Stay current with regulatory and industry VI trends.
• Participate in process validation activities.
• Design reject material classifications, trending, and response.
• Assist MSAT Lab in particulate management and defect libraries.
• Defend VI program in regulatory inspections and Pre-Approval Inspections.
• Gather data, perform root cause analysis, and drive process control changes.

Skills

Visual inspection systems

cGMP regulations

Data analysis

Process improvements

Project management

Communication

Problem solving

Education

Bachelor's or Master's degree in Engineering/Pharmaceutical Sciences

Tools

Statistical tools

Job description

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:

We are seeking a Visual Inspection (VI) expert with a focus on providing end to end VI program management. As a Process Engineer, you will play a crucial role in developing a compliant end to end VI process from kit building and Knapp to high-speed automated inspection (including automated eject inspection) and all steps in-between. This opportunity is to provide VI program leadership in a highly automated greenfield facility and develop with a cross-functional team the program from the ground up. As a member of this team, you will work closely with Manufacturing, Asset Engineering, Automation, and Quality Assurance, to develop an innovative and highly automated VI process and then maintain and change manage that process into commercial production.

• You will provide technical expertise and support for visual Inspection operations (syringe and cartridge), including process development, optimization, troubleshooting, and improvement initiatives
• You will provide technical support and expertise for drug product manual visual inspection, semi-automated Inspection, and automated inspection operations
• You will act as primary point of contact to the Global MSAT network for VI
• You will keep up on regulatory and industry trends in VI
• You will participate in process validation activities
• You will design reject material classifications, trending, and response
• You will assist with MSAT Lab in design of particulate management program and defect libraries.
• You will defend overall VI program in regulatory inspections in Pre-Approval Inspections
• You will perform data gathering, root cause analysis, and performance trending to develop appropriate process control changes for complex issues
• You will support deviation investigations and root cause analyses from a product impact and process perspective
• You will recommend and support implementing corrective and preventive actions as necessary.
• You will participate in product complaint assessments and or investigations, and other related post-market surveillance activities as needed
• You will utilize Lean Production System elements and methods to continuously improve tactical business processes and procedures
• You will participate in technology transfer activities from development to commercial manufacturing, ensuring successful scale-up and process validation

Who you are:

• You have a Bachelor's or Masters degree in Engineering, Pharmaceutical Sciences, or a related technical field and 8+ years of experience in cGMP operations
• You have strong knowledge of cGMP regulations and quality systems, with experience working in a regulated environment
• You have proven ability to implement process improvements
• You are recognized as an expert with visual inspection systems, including automated, semi-automated, and manual processes in a cGMP environment
• You are proficient in data analysis and statistical tools for process monitoring and optimization.
• You are detail-oriented with strong analytical and problem-solving skills, with the ability to identify root causes and implement effective corrective actions
• You have strong written and verbal communication
• You have an ability to work independently and challenge the status quo, handle multiple projects, prioritize and delegate effectively, adapt to changes quickly, and work collaboratively on cross-functional teams
• You have demonstrated project management skills

Preferred:

• You have experience with qualification and validation protocols
• You have familiarity with Lean Six Sigma principles and continuous improvement methodologies

Work Environment/Safety Considerations:

This role requires full onsite work at the project office before transitioning to the