The Opportunity:

We're seeking 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 our state-of-the-art manufacturing site. 

Your 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. This involves partnering and collaborating 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.

Key Start-up Responsibilities:

• You will collaborate closely with the Roche VI network, industry experts, and technology suppliers to implement the latest, fit-for-purpose Vision Technology.

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

• You will 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.

• You will ensure optimum equipment selection through qualification in place to deliver a Vertical Ramp Up with high quality defect detection and minimal waste. 

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

• You will build long term training plans, provide knowledge and training on complex process and equipment technologies to all required partners. You will provide training materials and training for people joining the organization. You will act as a coach for colleagues with less experience and help them develop skills/expertise. 

• Together with the suppliers and contractors, you will build all required processes, documents, tests to transition the 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 AVI Business Unit, which delivers a high-speed inspection program of the highest quality. In this sustained operations phase, you will:

• You will become the Engineering process expert for all site Machine Vision systems.

• You will drive Continuous Improvement and optimization to improve quality, yield and OEE of the assets.

• You will monitor and analyze machine performance, trend data and performance parameters to predict and proactively improve the program. 

• You will 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. 

• You will own the equipment knowledge library and change management.

• You will manage all New Product Introductions into the operation.

• You will 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.

• You 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. 

Who you are:

• You hold a Bachelor’s degree in bio/chemical engineering or similar and have 12+ years experience in the pharmaceutical industry with 5+ years in Automated Visual Inspection for parenteral drug manufacturing. 

• You are a recognized expert (technical and/or operational) in Visual Inspection drug product manufacturing.

• You have relevant experience in data science/engineering, analytics, IT etc. to drive the concept of smart factory is desirable

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

Preferred:

• You are 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.

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

• You are a recognized expert/recognized authority in practical and theoretical engineering of biopharmaceutical manufacturing processes. 

• You have 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.

• You have 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. You are able to coach others.

• You have up-to-date knowledge of cGMP’s, Health Authority regulations, and Quality Systems.

Work Environment/Safety Considerations:

• Ability to work in an international/global environment. Domestic and international travel required. Travel up to 20% after full relocation.

• May work in the clean room environment that requires gowning in the form of hospital scrubs, bunny suits, gloves, and steel toe boots.  

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

This role will require full onsite work at the project office before transition to the site offices once complete.

The expected salary range for this position in Holly Springs, NC is $114,400 - $212,400. 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.

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