Sr. Packaging Engineer

The Position Objectives and Scope of Position Behind every presentation of each product sold by Roche is the involvement of Pharma Global Technical Operations (PT). Starting with Phase I of the development process and continuing through to product maturity, PT makes medicines at sites around the world and includes more than 10 000 employees worldwide. "Global Technical Development" (PTD) is an organization of over two thousand people globally that are integral for the mission of Roche to develop meaningful medicines for patients. Therefore, we actively collaborate and develop creative technical solutions to bridge early-stage, late-stage and commercial product needs. The mandate of the group is, to expertly deliver the pipeline and supply quality products to patients. The group excels in its work through innovation, teamwork, dedication, and mutual respect and contributes every single day, continuously improving what it does. “U.S. Biologics Technical Development” (PTDU) develops and supports manufacturing processes, formulations, delivery devices, analytical methods, packaging solutions and materials to meet end-to-end (discovery to commercialization) development needs of the gRED protein pharmaceutical pipeline through innovation, efficiency, and collaboration to enable the delivery of novel medicines that can meet the critical needs of patients. In the Device and Packaging Development Department (PTDU-D), we are responsible for the development of medical devices, combination products and packaging systems for R&D portfolio drug products. Our activities comprise a wide range of engineering disciplines ranging from the initial definition of product requirements to first commercialization and subsequent product care considering required regulatory, legislative, ecological, economical and technical aspects. As a Sr. Packaging Engineer, you support the establishment of a world-class packaging organization by providing technical expertise in the development, qualification and deployment of new packaging systems. You will work on a variety of packaging initiatives and lead the development and qualification of global packaging solutions of assigned projects for clinical and commercial use. You will play a vital role in designing the best packaging for new molecules coming through the pipeline and launches. This activity involves close cooperation and cross-functional interaction with Technical Development Teams, Regulatory, Operations, CMO’s, Quality, Suppliers and other involved stakeholders. Job Responsibilities General responsibilities: Lead packaging engineering projects within global teams in order to meet predefined timelines, quality, and budget. Deliver innovative, best in class packaging solutions to meet patient and business needs. Develop and qualify global packaging solutions for products through the packaging lifecycle, understanding customer needs and leveraging the organization. Innovate: Evaluate and screen new technologies, and new materials and/or packaging solutions based on patient, product, regulatory, business or technical requirements. Ensure compliance with international procedures and external regulations. Actively support a culture of knowledge sharing and interaction across packaging and device development teams. Education & Qualifications: This position requires a Bachelor degree in materials science, packaging engineering, mechanical engineering or related field; with a minimum of 5 yrs w/ Bachelors (or 3 yrs w/ Masters) working in packaging development lifecycle activities in the Pharma, Medical Device, Food or Cosmetic industry. For this position, you bring the following qualifications: Technical expertise in packaging design, test methods and packaging equipment and process qualification / validation. Hands-on experience in small molecule packaging development, including bottle and blister designs, material evaluation and selection including compendial testing, performance testing, CR-SF testing is a plus. Hands-on experience in packaging equipment and process qualification is a plus. Sound knowledge of legislation, regulatory guidance and industry standards for packaging (e.g. ISTA/ASTM, design and validation / qualification, ISO, USP/EU/JP Compendia, ICH, and 21 CFR Part4). Excellent documentation practices: user requirements, design control, specifications, qualification protocols/reports for packaging systems, risk assessments, and shipping qualification activities. Innovative spirit leading to industry best practices. Design thinking, design management, drives creativity. Project management skills and experience in cross-functional projects. Excellent presentation and interpersonal communication skills. Fosters team effectiveness, team spirit, team alignment, shares risks within the team beyond the function. English language proficiency required. Traveling is required approx. 10-20% The expected salary range for this position based on the primary location of South San Francisco is $95,900 - $178,100. 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 Who we are A member of the Roche Group, Genentech has been at the forefront of the biotechnology industry for more than 40 years, using human genetic information to develop novel medicines for serious and life-threatening diseases. Genentech has multiple therapies on the market for cancer & other serious illnesses. Please take this opportunity to learn about Genentech where we believe that our employees are our most important asset & are dedicated to remaining a great place to work. Unless entitled to a reasonable accommodation under applicable law, employees are required to be fully vaccinated against COVID-19 in accordance with customer requirements, the company’s health and safety obligations and/or applicable law or guidelines. Diversity and Inclusion (D&I) are critical to the success of our company and our impact on society. We believe that by championing diversity of background, thought and experience, we can foster a sense of belonging and provide an environment where every employee feels valued, included, and able to contribute their best for the patients we serve. We’re focused on attracting, retaining, developing and advancing our people to their full potential by rewarding bold ways of thinking and integrating inclusive behaviors into every aspect of our work. Genentech is an equal opportunity employer, and we embrace the increasingly diverse world around us. Genentech prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin or ancestry, age, disability, marital status and veteran status. For more information about equal employment opportunity, visit our Genentech Careers Homepage. We believe it’s urgent to deliver medical solutions right now – even as we develop innovations for the future. We are passionate about transforming patients’ lives. We are courageous in both decision and action. And we believe that good business means a better world. That is why we come to work each day. We commit ourselves to scientific rigor, unassailable ethics, and access to medical innovations for all. We do this today to build a better tomorrow. We are proud of who we are, what we do, and how we do it. We are many, working as one across functions, across companies, and across the world. We are Roche.

Salary : $95,900 - $178,100