Packaging Engineer Contractor

This role is will manage CMO activities including all the documentation requirements of Packaging operationsKnowledge of cGMP docuemntation requirements a mustKnowledge and experienced use of trackwise a mustKnowledge of developing and experience in qualifying packaging components on packaging equipment a mustManagement (development, review and approval of) new and modifications to technical profile drawings and purchasing/release specifications a mustAbility to multi task and achieve tactical deliverables with little to no supervision, while understanding strategic impact trainingSupport team in substantiating and qualifying alternate component substrates, suppliers, and processes to mitigate risk of supply the development (input), launch, life cycle management and continuous improvement of primary and/or, Lead or own change control, non-conformances and CAPA activities working with Quality and Global Labeling OperationsManage implementation of platform (harmonization / standardization) components Manage bill of materials, etc.Candidate will facilitate template inclusion of regulatory (serialization)and global corporate standard labeling requirements (i.e. authentication)Scope of work includes all commercial products in the Biologics, Synthetic and Oncology portfolio, packaged within the internal packaging Network and approved contract manufacturing organizations (CMO’s) throughout global footprint with focus on EU/ROW.Candidate will function EU based above site Packaging Engineer SME. Is responsible, as an individual contributor to managing ALL impacted changes for the group, in US, EU and Rest of World markets GSQ PortfoilioThis role is to support external CMO Packaging Engineering but may include projects/product supplied both from internal and external CMO operations.cGMP SME in packagingTechnical specification, profile drawing development, review and approvalPackaging Process ValidationSpecification development, review, approval and implementationManaging quality documentation systems such as Veeva or Trackwise (change control, deviation/investigation and CAPA initiation, review and approval mechanisms a must)Qualification:Maternity Leave Cover (could be extended)Bachelor’s Degree in an engineering related field; Packaging Engineers preferred5 years pharmaceutical experience (or equivalent)Strong knowledge of cGMP documentation requirementsStrong technical, interpersonal, communication and leadership skills.Demonstrated abilities to manage and collaborate across internal stakeholders such as packaging colleagues, quality…Demonstrated strength in cross boundary communication, influencing others, working in cross-functional teamsDemonstrated organizational skills including project managementKnowledge of electronic documentation systems (ideally Trackwise)Requirements:Start: Duration: 14 monthsLocation: Zurich, Switzerland (maximum 8 days on-site per month) #J-18808-Ljbffr