Junior CSV Engineer
Il y a 1 heure
East Flanders, Flanders, Belgique
MindCapture
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h3System Specialist | Digital Manufacturing Systems | Ghent /h3 pAre you passionate about digital transformation, automation and improving manufacturing processes in the life sciences industry? /p pWe are looking for a bSystem Specialist /b to support our client in Ghent with the implementation and optimisation of digital and automated manufacturing systems. /p pIn this role, you will bridge the gap between manufacturing operations and technology, translating business requirements into robust, compliant and user friendly system solutions. You will contribute to system design, configuration, testing and validation while collaborating with experts across multiple disciplines. /p pWe offer competitive salaries, a full benefits package (meal vouchers, eco vouchers, DKV health insurance, group insurance, net expense allowance, and a company car). You also get the opportunity to shape your future through personalised training and development. /p pAt MindCapture, you choose what you love, build on your strengths, and make a difference where it matters most. /p pYou will work as a MindCapture consultant for an international market leader in the healthcare industry. /p h3Job Description: /h3 pAs a System Specialist, you will support the development, implementation and continuous improvement of digital manufacturing systems within a highly regulated biopharmaceutical environment. /p pYour responsibilities will include: /p ul liTranslate manufacturing, process and user needs into clear functional requirements, workflows and system specifications. /li liCollaborate with system engineers, technical experts and external vendors to ensure appropriate system configuration and implementation. /li liSupport the design, configuration and optimisation of digital manufacturing systems, including Manufacturing Execution Systems (MES) and enterprise applications. /li liWork closely with manufacturing, process experts, Quality Assurance, Engineering and IT to develop effective system solutions. /li liEnsure critical process, product, data integrity and compliance requirements are incorporated into system designs. /li liSupport system changes and new functionalities in accordance with established change control and validation procedures. /li liPrepare and review functional specifications, test protocols, qualification documents, SOPs and work instructions. /li liExecute system testing, including User Acceptance Testing (UAT), while documenting results and ensuring compliance. /li liSupport validated system implementation, operational readiness and handover to end users. /li liDevelop training materials and provide training to end users on implemented systems. /li liSupport system interfaces, data flows and integration between connected manufacturing applications. /li liContribute to standardisation, scalability and continuous improvement of digital solutions. /li /ul h3Requirements: /h3 ul liBachelor’s or Master’s degree in Biotechnology, Bioengineering, Pharmacy, Industrial Automation, Computer Science, Electromechanics or a related scientific or technical field. /li libMinimum 1.5 years of relevant professional experience /b, preferably within a manufacturing, engineering or life sciences environment. /li liExperience or strong affinity with digital manufacturing systems, computerised applications and automation technologies. /li liKnowledge of business process modelling, business analysis and translating operational requirements into functional specifications. /li liFamiliarity with bManufacturing Execution Systems (MES) /b and enterprise software applications. /li liGood understanding of manufacturing processes and their interaction with quality, maintenance, testing and engineering. /li liKnowledge of GMP principles and working within a regulated environment is an advantage. /li liExperience with computerised system validation, system testing or User Acceptance Testing is beneficial. /li liExperience with MES configuration, system integration or systems engineering is an advantage. /li liExperience within a cell and gene therapy manufacturing environment is a plus. /li liStrong analytical thinking, problem solving skills and a pragmatic approach. /li liAbility to work independently, manage multiple priorities and adapt to changing project requirements. /li liExcellent communication and interpersonal skills with a strong focus on teamwork. /li liQuality driven mindset with attention to detail, compliance and continuous improvement. /li liProactive attitude, willingness to learn and ability to collaborate effectively with multidisciplinary teams. /li libProfessional working proficiency in English is required. /b Dutch or French is an advantage. /li /ul pAre you ready to make a real difference in healthcare? /p pIf MindCapture sees a potential fit, we’ll get in touch as soon as possible. /p pIf you don’t hear from us within two weeks, it simply means that this particular position wasn’t the right match. In that case, we’ll glad