Job TitleJob Responsibilities:Develop and qualify global primary and secondary packaging solutions for sterile, non-sterile and combination products, including author/co-author the related packaging specifications and qualification documentationQualification of global packaging solutions in line with the current validation requirements (e.g. Development of test protocols and reports, risk assessment, execute IQ/OQ/PQ, and shipping qualification)Maintenance of global packaging solutions (e.g. support change control records, provide impact assessments, execute requalification)Evaluate and develop new materials and/or alternate packaging materials, packaging solutions or packaging systems based on product, regulatory, business or technical requirementsSupport or lead projects delivering innovative packaging technologies and systems under Roche global packaging technology centersEducation & Qualifications: Personal Requirements:Bachelor degree, preferably with an engineering degree in packaging, materials science, or a related fieldAt least 1 year working experience in relevant fieldProficient technical leadership, collaboration and communication skillsEnglish language proficiency requiredTechnical Requirements:Knowledge of packaging testing methodologies and standards including, shock, drop and vibration testing, peel force and tensile testing, barrier analysis, CCI/Sterile integrity, DIN, ISO, ISTA, USP, FDA, MHRA and ASTM standards for packaging design and validationKnowledge of packaging process equipment, related to steriles, and non-steriles, and combination products packaging activities (e.g. vials, PFS, devices, aseptic form/fill/seal, blister and bottle filling lines), printing systems and serializationKnowledge on equipment IQ, OQ, and PQ and development of qualification protocols / reports for packaging and shipping qualification activitiesKnowledge of design control for combination productsWorking knowledge of computer systems including TOPS, CAD or Solidworks, and Microsoft tools including MS project, and AdobeKnowledge of industry best practices and technical writing skills such as GMP and GDP
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