Device Technology Deployment Manager – Assembly & Packaging

F. Hoffmann-La Roche AG; Holly Springs (MS); On-site; USD 110,000 - 204,000; Full time

Job summary

Genentech, a Roche subsidiary, seeks a Device Technology Deployment Manager focused on automated device assembly and packaging. You will lead complex technology deployment projects across our global network, translating product requirements into scalable manufacturing solutions and providing technical leadership throughout design, qualification, and production rollout.

You bring a strong background in device manufacturing, ISO 13485/GDP, and cGMP with 7+ years in regulated environments, and are

Qualifications

• Bachelor's (B.S.) or Master's (M.S.) degree in Engineering or related technical discipline.
• 7+ years of relevant experience in medical device manufacturing or similarly regulated environments.
• Strong hands-on experience with automated device assembly equipment and processes.
• Experience with final device assembly technologies and automated packaging equipment is strongly preferred.
• Experience taking complex manufacturing equipment from concept through design, FAT, SAT, commissioning, qualification, and production implementation.
• Solid understanding of cGMP and ISO 13485/FDA requirements.
• Fluency in English and willingness to travel internationally up to ~25%.

Responsibilities

• Lead end-to-end deployment of automated device assembly and packaging technologies from concept through industrial rollout.
• Translate product and process requirements into robust equipment concepts and scalable manufacturing solutions.
• Provide technical leadership for development and deployment of automated assembly platforms.
• Drive equipment and process tech initiatives to improve robustness, efficiency and future readiness.
• Evaluate new assembly technologies through feasibility studies and pilots for potential deployment.
• Lead equipment design reviews, machine risk assessments, FAT/SAT, commissioning, qualification, and process validation.
• Ensure deliverables meet product and process requirements in collaboration with Site Engineering, Quality, and external suppliers.
• Lead collaboration with equipment suppliers including selection, technical clarifications, and documentation reviews.

Skills

Project leadership

Stakeholder management

Communication

Negotiation

Education

Bachelor's or MS in Engineering

Tools

UR S through validation

Job description

PTT (MSAT & Engineering) is responsible for ensuring that Pharma Technical Operations stays at the forefront of manufacturing technology. We integrate product and process understanding with equipment capability and facility readiness to enable robust, efficient, and future-ready manufacturing across our global network. Global MSAT ensures seamless technical product lifecycle management, develops and deploys new technologies and network standards, systematically improves processes across the pharma portfolio, solves operational challenges through data-driven insights, and enables the sustainable scaling of innovations across the network. Within Global MSAT, Device Manufacturing Engineering defines and drives manufacturing process characterization, technology development, and industrialization for Roche medical devices and drug-device combination products throughout their lifecycle. We are looking for a Device Technology Deployment Manager with a strong focus on automated device assembly and packaging technologies. In this role, you will lead the technical deployment of manufacturing equipment and processes across our global network- translating product and process requirements into robust, scalable, and compliant manufacturing solutions.

The Opportunity

As Device Technology Deployment Manager, you will lead complex technology deployment projects from early concept through industrial implementation. You will work at the intersection of device technology, process engineering, equipment engineering, automation, quality, and manufacturing.

Your key responsibilities include:

• Lead end-to-end deployment of automated device assembly and packaging technologies, from concept assessment and equipment selection through design, FAT/SAT, commissioning, qualification, and manufacturing implementation.
• Translate product and process requirements into robust equipment concepts, technical specifications, and scalable manufacturing solutions for device assembly and packaging.
• Provide technical leadership for the development and deployment of automated and high-speed device assembly and packaging platforms.
• Drive strategic equipment and process technology initiatives to improve manufacturing robustness, efficiency, automation, and future readiness across the product lifecycle.
• Evaluate new assembly and packaging technologies through feasibility studies, pilots, and technical assessments and determine their readiness for industrial-scale deployment.
• Provide technical leadership during equipment design reviews, machine risk assessments, FAT/SAT, commissioning, qualification, and process validation.
• Ensure critical design, qualification, and validation deliverables are technically sound and aligned with product and process requirements, working closely with Site Engineering, Quality, Device Development, MSAT, Automation, and Manufacturing.
• Lead technical collaboration with equipment suppliers, including supplier selection, technical clarification, design development, performance management, and review of critical technical documentation.
• Support the development and harmonization of global manufacturing technology standards and platform solutions for device assembly and packaging.

Who You Are

We are looking for an experienced and technically strong individual who combines deep device manufacturing knowledge with the ability to lead complex technology deployment projects in a global, highly regulated environment. You bring:

You Bring:

• A Bachelor's (B.S.) or Master's (M.S.) degree in Engineering, such as Mechanical Engineering, Automation, Biomedical Engineering, Process Engineering, or a related technical discipline.
• 7+ years of relevant experience in medical device, drug-device combination product, pharmaceutical, or similarly regulated manufacturing environments.
• Strong hands-on experience with automated device assembly equipment and processes, preferably including drug-delivery devices such as autoinjectors or pen injectors, and associated inspection and handling technologies.
• Experience with final device assembly technologies and automated packaging equipment is strongly preferred.
• Demonstrated experience taking complex manufacturing equipment from concept and URS through design, FAT, SAT, commissioning, qualification, and production implementation.
• Strong understanding of equipment and process development, including URS, design reviews, machine risk assessments, commissioning and qualification strategies, process characterization, and validation.
• Proven ability to support process development and technology scaling from early feasibility studies through New Product Introduction and commercial manufacturing.
• Experience working with equipment suppliers and leading technical discussions across multidisciplinary and cross-functional project teams.
• Solid understanding of cGMP and relevant medical device quality requirements, including ISO 13485 and applicable FDA requirements.
• Strong communication, negotiation, influencing, and stakeholder management skills across technical functions, manufacturing sites, and external suppliers.
• Fluency in English and willingness to travel internationally up to approximately 25%, particularly for supplier activities, FATs, and site implementation.
• Relocation benefits are not available for this posting.

The expected salary range for this position based on the primary location of NC/OR, is $109,900 to $204,100. Actual pay will be determined based on experience, qualifications, geographic location, and other job-related factors permitted by law. A discretionary annual bonus may be available based on individual and Company performance. This position also qualifies for the benefits detailed at the link provided below.

Benefits #LI-PK1 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 company's 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.

Who We Are

Genentech, a member of the Roche group and founder of the biotechnology industry, is dedicated to pursuing groundbreaking science to discover and develop medicines for people with serious and life-threatening diseases. To solve the world's most complex health challenges, we ask bigger questions that challenge our industry and the boundaries of science to transform society. Our transformational discoveries include the first targeted antibody for cancer and the first medicine for primary progressive multiple sclerosis. The next step is yours.

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 company's 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.

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.