Senior Principal Engineer, Inspection

Genentech • Cary, NC

19h • Onsite

About The Position

Welcome to Holly Springs, North Carolina— home to Genentech's largest-ever investment with an ambitious goal to be a fully connected Plant of the Future. This is where next-generation technology, capability, digital connectivity and Operational Excellence converge to create the global standard for high-volume, highly-efficient Drug Product manufacturing, including Component Prep & Compounding, Liquid PFS Filling, Automated Inspection, Autoinjector Assembly, and Packaging/Finished Products. 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 will not only meet today’s demand for CVRM (Cardiovascular, Renal, and Metabolism) medicines but is a strategic commitment to be scalable with this portfolio, which serves one of the largest patient populations in the world. This is a fast-paced, highly entrepreneurial environment with a high-level of accountability from the site team to launch operations in 2028. The opportunity is for a highly experienced and strategic Senior Principal Engineering Leader to oversee the design, qualification and operational startup of the Automated Visual Inspection (AVI) program in this state-of-the-art manufacturing site. The initial focus will be to provide scientific, technical, and operational leadership to establish the new AVI operation within the Drug Product Fill and Finish facility, partnering with the Engineering Delivery team, equipment suppliers, the newly formed local site team and Roche/Genentech network Visual Inspection teams to establish a green-field AVI program from the ground-up.

Requirements

• Hold a Bachelor’s degree in bio/chemical engineering or similar.
• 12+ years experience in the pharmaceutical industry.
• 5+ years in Automated Visual Inspection for parenteral drug manufacturing.
• Recognized expert (technical and/or operational) in Visual Inspection drug product manufacturing.

Nice To Haves

• Relevant experience in data science/engineering, analytics, IT etc. to drive the concept of smart factory is desirable.
• Prior experience with technology transfers, process validation, authoring regulatory submissions, and Health Authority inspections is desirable.
• Able to organize and solve complex, unique or unprecedented problems through the regular use of ingenuity and innovation; consistently demonstrating courage and drive to ensure optimal business results.
• Advanced project management skills: demonstrated ability of technology implementation and start-up.
• Recognized expert/recognized authority in practical and theoretical engineering of biopharmaceutical manufacturing processes.
• Relevant contact with collaborators, regulatory agencies, and vendors inside and outside the company including coordination across organizational lines, including advising and influencing senior management on advanced technical matters.
• Utilizes an established network for technical issues within the company and the industry.
• Strong organizational and interpersonal skills: can get things done in a way that optimizes results, strengthens internal and external relationships, and with consideration of resources.
• Able to coach others.
• Up-to-date knowledge of cGMP’s, Health Authority regulations, and Quality Systems.

Responsibilities

• Collaborate closely with the Roche VI network, industry experts, and technology suppliers to implement the latest, fit-for-purpose Vision Technology.
• Contribute expertise in project management, technical design, testing, qualification, recipe development and validation to ensure successful installation, qualification and validation of the program.
• Ensure the overall AVI program, to include defect program, operator qualification program, general operating procedures, maintenance and calibration programs meet the latest and highest global health authority, regulatory standards for successful registration and filing.
• Ensure optimum equipment selection through qualification in place to deliver a Vertical Ramp Up with high quality defect detection and minimal waste.
• Be an integral part of selecting, training, qualifying, and mentoring Operators and Maintenance Technicians.
• Build long term training plans, provide knowledge and training on complex process and equipment technologies to all required partners.
• Provide training materials and training for people joining the organization.
• Act as a coach for colleagues with less experience and help them develop skills/expertise.
• Together with the suppliers and contractors, build all required processes, documents, tests to transition the design plans into a functioning, approved manufacturing process.
• Become the Engineering process expert for all site Machine Vision systems.
• Drive Continuous Improvement and optimization to improve quality, yield and OEE of the assets.
• Monitor and analyze machine performance, trend data and performance parameters to predict and proactively improve the program.
• Keep up to date with the latest in industry changes and regulatory requirements on Machine vision systems to keep the site compliant - presenting the site AVI program to Health Authorities as needed.
• Own the equipment knowledge library and change management.
• Manage all New Product Introductions into the operation.
• Foster a positive safety culture in which no one gets hurt and ensure the integration of environmental health, safety, and security into the business and manufacturing processes, systems, and programs while reporting safety and environmental incidents within one’s functional area.
• Understand the bigger picture of the project and large volume low cost manufacturing as part of the CVRM disease area and how Pharma Technical (PT) contributes to it.

Benefits

• Relocation benefits are provided.
• A discretionary annual bonus may be available based on individual and Company performance.
• Genentech is an equal opportunity employer.
• Accommodations for Applicants with disabilities.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Number of Employees: 5,001-10,000 employees