Principal Packaging Engineer
vor 4 Wochen
Roche fosters diversity, equity and inclusion, representing the communities we serve. When dealing with healthcare on a global scale, diversity is an essential ingredient to success. We believe that inclusion is key to understanding people's varied healthcare needs. Together, we embrace individuality and share a passion for exceptional care. Join Roche, where every voice matters.
The PositionWe advance science so that we all have more time with the people we love.
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.
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.
In the Global Device and Packaging Development Department (PTDZ), 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 considering required regulatory, legislative, ecological, economical and technical aspects.
Within the PTDZ organization sits a Global Packaging Development team responsible for designing and qualifying primary and secondary packaging systems for Roche global pipeline molecules including solid dosage forms, injectables, cell and gene therapies and combination products. As a Principal Packaging Engineer, you will provide technical expertise in the development, qualification and deployment of new packaging systems, with a work plate heavily focused on leading pharmaceutical primary container and closure system topics for various therapeutical modalities such as biologics, small molecules, and gene & cell therapies. 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, MSAT, Operations, CMO's, Quality, Suppliers and other involved stakeholders.
The Opportunity- Lead packaging engineering projects within global teams to meet predefined timelines, quality, and budget, while successfully collaborating with stakeholders (Distribution Technology, CMO, Procurement, Quality, Packaging Operations, Local Packaging Development, etc.).
- Deliver innovative, best-in-class packaging solutions to meet patient and business needs by developing and qualifying global packaging solutions through the packaging lifecycle, understanding customer needs, and leveraging the organization.
- Innovate by evaluating and screening new technologies, materials, and packaging solutions based on patient, product, regulatory, business, or technical requirements while ensuring compliance with international procedures and external regulations.
- Provide consultancy services/support, write expert reports, and actively support a culture of knowledge sharing and interaction across packaging and device development teams.
- Represent the function in cross-functional review boards, create strategic alliances, initiate improvements with stakeholders, and maintain a network in the packaging specialist area by participating in relevant professional bodies.
- Bring and develop packaging expertise into the organization, functioning as a key communication interface between Marketing, Manufacturing, Contract Manufacturing, Quality, and suppliers.
This position requires a Bachelor degree in materials science, mechanical, chemical, packaging engineering or related field; with a minimum of 8+ yrs w/ Bachelors working in packaging development lifecycle activities in the Pharma and/or Medical Device industry.
- Technical expertise and hands-on experience in packaging design, test methods, packaging equipment, and process qualification/validation, along with a 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 Part 4).
- Excellent documentation practices, including user requirements, design control, specifications, qualification protocols/reports for packaging systems, risk assessments, and shipping qualification activities.
- Excellent project management skills and experience in cross-functional projects, along with innovative spirit leading to industry best practices through design thinking, design management, and driving creativity.
- Fosters team effectiveness, team spirit, team alignment, shares risks within the team, and promotes a culture of continuous improvement.
- Ability to work in a dynamic, high-paced environment, learn quickly, be flexible with changing roles and responsibilities, and effectively collaborate and build networks with internal and external stakeholders.
- Excellent presentation, interpersonal communication, and problem-solving skills, with proficiency in English (German is an asset) and notions of statistical analysis.
This position is located at Roche's global headquarters in Basel, Switzerland. Traveling is required approx. 10-20%.
Who we areAt Roche, more than 100,000 people across 100 countries are pushing back the frontiers of healthcare. Working together, we've become one of the world's leading research-focused healthcare groups. Our success is built on innovation, curiosity and diversity.
Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 10,700 employees from over 100 countries come together at our Basel/Kaiseraugst site, which is one of Roche`s largest sites. Read more.
Besides extensive development and training opportunities, we offer flexible working options, 18 weeks of maternity leave and 10 weeks of gender independent partnership leave. Our employees also benefit from multiple services on site such as child-care facilities, medical services, restaurants and cafeterias, as well as various employee events.
We believe in the power of diversity and inclusion, and strive to identify and create opportunities that enable all people to bring their unique selves to Roche.
Roche is an Equal Opportunity Employer.
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