The Opportunity:

We're 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 facility's go-live, you will transition to supporting the ongoing Packaging Business Unit. In 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 compliance—presenting 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 Bachelor’s 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 Master’s, 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 $95,000 - $186,000 (Principal Engineer) and $114,400 - $212,400 (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.