JOB DESCRIPTION:The role focuses on delivering process and qualification studies for packaging process and cold chain shipments. This involves issuing risk assessments, protocols, executing or coordinating the execution of tests and writing reports.Other important aspect of this position is to design new materials templates and/or specifications in SAP Packaging Solutions. Evaluate new markets and/or changes in the formats in the packaging line. Evaluate and develop a new process format maintenance process and create new formats in the packaging line equipment. Evaluate from a MDCP (Medical Device and Combination Products) perspective.Other important aspects of the position are continuous improvement of current operations to improve OEE, quality and/or productivity using current OpEx methodologies including the design and execution of protocolized development studies required to achieve those gains.Troubleshooting of packaging and shipping operations, collaborating to resolve process and technical issues. Perform Process Risk Assessments and implement controls to decrease risks detected.Perform product and process impact assessments derived from change controls or investigations.Perform periodic reviews of shipping routes and cold-chain shipments to different markets around of the world.JOB RESPONSIBILITIES: Author protocols for process and shipping validation, execute the validation studies in partnership with Operations Departments and write validation reportsLead Quality risk assessmentsElaborate SOPs related to Packaging Technical Services and maintain all documentation updatedImplement Continuous Improvements in the different operational areas: author development protocols, execute or coordinate execution of technical experimental studies and write technical reportsEnsures that projects and commitments are completed on schedule.Supports troubleshooting and resolution of process deviations. Performs root-cause analysis and identifies appropriate, effective corrective and preventive actions.Process and Product Impact Assessments (for deviations, quality risk analysis and change control)Manage major changes to manufacturing process through site Change Control systemAbility to gather, analyze, interpret and compare information from multiple sources and identify cause and effect relationshipsDesign new materials templates and specificationsSupport Compliance Inspections and enquiries from regulatory agenciesParticipate in cross-functional project teams as applicable to enable equipment design, installation and qualification, technology transfer and New Product Introductions.Evaluate new materials, packaging components (secondary and tertiary) and shipping containers“On-the floor” technical support to Operations.Develop and maintain productive links with Operations, Quality and Engineering & Maintenance experts across the site to maintain up to date technology skills and knowledge base.ORGANIZATIONAL CHART: The incumbent will report nominally to the Packaging Technical Services ManagerThe incumbent will work in partnership with Packaging and Warehouse Managers and technicians as well as Engineering, Artworks, Supply Chain and Quality functions within site and also with external stakeholders (e.g., GT&E…)QUALIFICATIONS:Must-haveBachelor´s Degree (or above) in Pharmacy, Chemistry, Engineering or other Life Sciences degree.At least two years of experience in the pharmaceutical industry in the areas of packaging product/process development, validation or manufacturing and cold chain shipmentsDemonstrated ability to provide technical solutions for complex problems through product and process knowledgeDemonstrated ability to lead change and strong collaborative skillsGMP knowledge is essential for this position.Experience of demonstrating strong customer focus, with ability to support day-to-day work when needed while remaining focused on implementing continuous process improvement changes to meet long-term goals.Knowledge of packaging equipment, cold chain shipments and storage chambersDemonstrated success track record in working collaboratively in complex matrix environments is essentialGood English communication skills (oral and written) are required.Nice-to-haveMaster´s degreeRelevant pharmaceutical industry experience in Secondary Packaging AreaMDCP (Medical Device and combination Products) knowledgeWORKER TYPE:Temporary