PrincipalSenior Principal Engineer, Packaging (Holly Springs)

Welcome to Holly Springs North Carolina home to Genentechs 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. This will include component prep & compounding liquid PFS and cartridge filling automated inspection autoinjector/pen assembly labeling and packaging.

The facilitys 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 todays 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.

Are you a problem-solver and change agent who thrives in a high-performing Team environment eager to tackle the most complex manufacturing challenges If so this is a once-in-a-lifetime opportunity to not only launch a state-of-the-art facility from the ground-up but to shape the culture of our organization for the next generation.

Join us in Holly Springs where you wont just build a plantyou will build the future of medicine.

The Opportunity:

Were seeking a highly experienced and strategic Principal/Senior Principal Engineer to oversee the design qualification and operational startup of the Packaging area in our state-of-the-art manufacturing site.

Your initial focus will be to provide scientific technical and operational leadership to establish the new Packaging operation within the Drug Product Fill and Finish facility. This involves partnering and collaborating with the Engineering Delivery team equipment suppliers the local User team and Roche/Genentech network Device development and Packaging teams to establish a greenfield packaging program from the ground-up.

Key Start-up Responsibilities:

• You will collaborate closely with the Roche/Genentech network industry experts and technology suppliers to implement the latest fit-for-purpose labeling and secondary packaging technology ( de-traying labeling cartoning case packing palletizing etc.).

• You will contribute expertise in project management technical design testing qualification recipe development and validation to ensure the successful installation qualification and validation of the program.

• You will ensure the overall Packaging program including operator qualification general operating procedures maintenance and calibration programs meets the latest and highest global health authority and regulatory standards for successful registration and filing.

• You will ensure optimum equipment selection and qualification are in place to deliver a Vertical Ramp Up with high output efficiency and minimal waste.

• You will be an integral part of selecting training qualifying and mentoring Operators and Maintenance Technicians.

• You will support development of long-term training plans and provide knowledge/training on complex process and equipment technologies to all required partners. You will provide training materials and act as a coach for colleagues helping them develop skills and expertise.

• Together with suppliers and contractors you will build all required processes documents and tests to transition design plans into a functioning approved manufacturing process.

Post Go-Live Responsibilities:

Following the facilitys go-live you will transition to supporting the ongoing Packaging Business this sustained operations phase you will:

• Become the Engineering process expert for all site packaging 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 industry changes and regulatory requirements on packaging systems to ensure site compliancepresenting the site program to Health Authorities as needed.

• Own the equipment knowledge library and change management.

• Manage New Product Introductions into the operation.

• Foster a positive safety culture and ensure the integration of environmental health safety and security into the business and manufacturing processes.

• Understand the bigger picture of the project large-volume low-cost manufacturing within the CVRM disease area and how Pharma Technical (PT) contributes to it.

Who you are:

• You hold a Bachelors degree in engineering or similar and have 8 years of experience (Principal) or 12 years of experience (Senior Principal) in the pharmaceutical industry with significant experience in packaging operations.

• You are a recognized expert (technical and/or operational) in drug product and combination products packaging including components processes and equipment.

• You have relevant experience in data science/engineering analytics and IT to drive the concept of a smart factory.

• You have prior experience with technology transfers process validation authoring regulatory submissions and Health Authority inspections.

Preferred Qualifications:

• You have a Masters or Ph.D.

• You are able to organize and solve complex unique or unprecedented problems through ingenuity and innovation; consistently demonstrating courage and drive to ensure optimal business results.

• You have advanced project management skills: demonstrated ability in technology implementation and start-up.

• You possess relevant experience coordinating with collaborators regulatory agencies and vendors including advising and influencing senior management on advanced technical matters.

• You have strong organizational and interpersonal skills: able to get things done by optimizing results and strengthening relationships. You are an effective coach.

• You have up-to-date knowledge of cGMPs Health Authority regulations and Quality Systems.

Work Environment/Safety Considerations:

• Ability to work in an international/global environment. Domestic and international travel required (up to 30% during the project phase 20% post startup).

• May work in a clean room environment requiring gowning (hospital scrubs bunny suits gloves and steel-toe boots).

• Potential to work near hazardous materials chemicals and equipment as per company safety procedures.

• This role requires full onsite work at the project office before transitioning to the site offices.

The expected salary range for this position based on the primary location of Holly Springs North Carolina is $95000 - $186000 (Principal Engineer) and $114400 - $212400 (Senior Principal Engineer). 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.

Link to Benefits

Genentech is an equal opportunity employer. It is our policy and practice to employ promote and otherwise treat any and all employees and applicants on the basis of merit qualifications and competence. The companys policy prohibits unlawful discrimination including but not limited to discrimination on the basis of Protected Veteran status individuals with disabilities status and consistent with all federal state or local laws.

If you have a disability and need an accommodation in relation to the online application process please contact us by completing this form Accommodations for Applicants.