pAs a Packaging Engineer, you will act as an EU-based subject matter expert supporting packaging activities across external Contract Manufacturing Organizations (CMOs), with potential involvement in internal packaging operations. /ppYou will manage packaging engineering activities and associated documentation across commercial pharmaceutical products, ensuring compliance with cGMP requirements and supporting changes throughout the product lifecycle. /ph3Requirements /h3ulliManage packaging engineering activities and documentation requirements across external CMO operations. /liliDevelop, review, approve and implement technical profile drawings and packaging component specifications. /liliSupport the development and qualification of packaging components on packaging equipment. /liliLead packaging process validation and qualification activities. /liliManage change controls, non-conformances, deviations/investigations and CAPA activities in collaboration with Quality and other cross-functional teams. /liliManage quality documentation within TrackWise and ensure documentation is complete, compliant and audit-ready. /liliSupport the qualification of alternative component materials, suppliers and processes to mitigate supply risks. /liliManage packaging component changes across US, EU and Rest of World markets. /liliSupport the implementation and standardisation of packaging components across platforms. /liliMaintain and manage Bills of Materials and associated packaging documentation. /liliSupport regulatory and corporate labelling requirements, including serialization and authentication requirements. /liliCollaborate closely with Packaging, Quality, Global Labeling Operations and other internal stakeholders, as well as technical experts at external CMOs. /liliManage multiple projects and priorities independently while ensuring delivery on time, in full and right first time. /li /ulh3Competences /h3ulliBachelor’s degree in Engineering or a related technical field; Packaging Engineering is preferred. /liliMinimum strong5 years of pharmaceutical industry experience /strong or equivalent relevant experience. /liliStrong hands-on experience within strongpharmaceutical packaging engineering /strong. /liliStrong knowledge of strongcGMP documentation requirements /strong. /liliProven experience developing and qualifying strongpackaging components on packaging equipment /strong. /liliExperience with strongpackaging process validation and qualification /strong. /liliStrong experience developing, reviewing and approving strongtechnical specifications, profile drawings and packaging component specifications /strong. /liliHands-on experience managing strongchange controls, deviations/investigations, non-conformances and CAPAs /strong. /lilistrongTrackWise experience is mandatory. /strong /liliExperience working with CMOs and external manufacturing environments is highly desirable. /liliStrong project management and organisational skills with the ability to manage multiple priorities independently. /liliComfortable working across functions, countries and time zones within a global matrix organisation. /liliStrong communication, stakeholder management and influencing skills. /li /ulpMaybe not for you, but for someone else? /p #J-18808-Ljbffr
Packaging Engineer Arbeitgeber: Swisslinx AG
Als Arbeitgeber bietet unser Kunde, eine führende Bank, ein dynamisches und unterstützendes Arbeitsumfeld, das auf Innovation und Zusammenarbeit setzt. Die Möglichkeit, an einem strategischen Transformationsprojekt im Bereich Financial Crime Compliance mitzuwirken, eröffnet Ihnen nicht nur spannende Herausforderungen, sondern auch hervorragende Entwicklungsmöglichkeiten in einem zukunftsorientierten Sektor. Zudem profitieren Sie von flexiblen Arbeitsmodellen und einer Unternehmenskultur, die Wert auf Vielfalt und persönliche Entfaltung legt.
