Help shape the future of biotechnology by leading packaging innovation, compliance, and global CMO partnerships across international markets. R&D Partners is seeking a Packaging Engineer to support external CMO packaging operations for a leading biotechnology company. This role focuses on managing CMO activities, documentation requirements, and packaging component qualifications. The position requires expertise in cGMP documentation, Trackwise systems, and packaging process validation. Please note that to be considered for this role you must have the right to work in this location. Responsibilities: Manage CMO activities, including documentation requirements for packaging operations. Develop, review, and approve technical profile drawings and purchasing-release specifications. Qualify packaging components on packaging equipment. Lead or own change control, non-conformances, and CAPA activities in collaboration with Quality and Global Labeling Operations. Support teams in qualifying alternate component substrates, suppliers, and processes to mitigate risks. Manage implementation of platform harmonization and standardization of components. Oversee packaging operations for commercial products across Biologics, Synthetic, and Oncology portfolios within internal networks and CMOs globally, with a focus on EU-ROW markets. Key Skills and Requirements: Education: Bachelor’s Degree in an engineering-related field (Packaging Engineering preferred). Experience: Minimum 5 years in the pharmaceutical industry or equivalent. Technical Expertise: Strong knowledge of cGMP documentation requirements. Proficiency in electronic documentation systems (Trackwise required). Experience in packaging process validation and specification development. Interpersonal Skills: Ability to multitask and deliver tactical results with minimal supervision. Strong communication and leadership skills. Team player with adaptability to work across time zones in a matrix organization. Language: Fluent in English. Scope: This role encompasses all commercial products packaged within internal networks and approved CMOs globally, focusing on EU-ROW markets. The candidate will act as an EU-based SME, managing impacted changes across US, EU, and Rest of World markets. #J-18808-Ljbffr
Packaging Engineer in Zürich Arbeitgeber: R Dpartners
R&D Partners bietet eine herausragende Arbeitsumgebung für Fachkräfte im Bereich der biopharmazeutischen Herstellung. Mit einem Fokus auf Innovation und Qualität fördern wir eine Kultur der Zusammenarbeit und des kontinuierlichen Lernens, die es unseren Mitarbeitern ermöglicht, sich sowohl persönlich als auch beruflich weiterzuentwickeln. Unser neuer Standort bietet nicht nur modernste Produktionsmöglichkeiten, sondern auch ein inspirierendes Umfeld, in dem Sie aktiv zur Gestaltung der Zukunft der mAb-Produktion beitragen können.
