Emploi: automation engineer projects support:Randstad.chJob description:
job detailspublié . 13. mai 2022 lieu . bern, berne secteur . life sciences type d'emploi . contract référence . 17569 contact . moutusi chattopadhyay, zurich professionals it téléphone . 058 201 56 67 appliquer > description du posteAutomation Engineer Projects support We are looking for a Automation engineer Project support who is having pharma or medical device experience for one of our globally renowned clients in the field of Pharma and Medical device . Assist the Senior Engineer in CAPEX projects: under his general supervision, this situation will perform and assist technical work, provide engineering and design services, and/or develops concepts, designs and details. . Preparation, review and approve technical and GMP related documentation (URS, FMEA, impact/risk assessment) focus on, but not limited to, CSV for new systems in collaboration with internal and external partner . Support for Change Control creation and tracking of defined action items . Contribution to ensure that changes to systems, procedures, processes and formulas are appropriately managed such that resulting impact on equipment / computerized systems commissioning and qualification process are assessed and resolved. . Compilation of costs for CAPEX application (supplier quotations, and internal workload estimation) . Management of all orders related to a project (delivery, delays, receipt, feedback) . Organization of meetings and status reporting Qualification . Bachelor/Master?s degree in technical or natural sciences . A minimum of 3 years of working experience . Experience in the pharmaceutical industry and GMP . Know-how of CSV requirements according to FDA 21CFR Part11/EU GMP Annex11 regulations and ISPE GAMP5 Guidelines . Technical understanding of the function of equipment and understanding of the offers and needs of the departments (Qualification, Engineering, Production) . Sound experience with various IT-tools, systems, especially MS . Excellent communication skills . Business fluency in German and English . Understanding of automation related topics is a plus . Understanding of finance and cost control is a plus . Quick learning ability and shown hands-on mentalityDont hesitate to apply. Good luck Skills:
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