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At Roche you can show up as yourself embraced for the unique qualities you bring. Our culture encourages personal expression open dialogue and genuine connections where you are valued accepted and respected for who you are allowing you to thrive both personally and professionally. This is how we aim to prevent stop and cure diseases and ensure everyone has access to healthcare today and for generations to come. Join Roche where every voice matters.
We 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 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 CMOs Quality Suppliers and other involved stakeholders.
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 Roches global headquarters in Basel Switzerland. Traveling is required approx. 10-20%.
A healthier future drives us to innovate. Together more than 100000 employees across the globe are dedicated to advance science ensuring everyone has access to healthcare today and for generations to come. Our efforts result in more than 26 million people treated with our medicines and over 30 billion tests conducted using our Diagnostics products. We empower each other to explore new possibilities foster creativity and keep our ambitions high so we can deliver life-changing healthcare solutions that make a global impact.
Lets build a healthier future together.
Roche is an Equal Opportunity Employer.
Required Experience:
Staff IC
Full-Time