Junior CSV Engineer

System Specialist | Digital Manufacturing Systems | Ghent Are you passionate about digital transformation, automation and improving manufacturing processes in the life sciences industry? We are looking for a System Specialist to support our client in Ghent with the implementation and optimisation of digital and automated manufacturing systems. In 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. Ready to grow your career and make real impact? Join MindCapture

We 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. At MindCapture, you choose what you love, build on your strengths, and make a difference where it matters most. You will work as a MindCapture consultant for an international market leader in the healthcare industry.

Job Description
As a System Specialist, you will support the development, implementation and continuous improvement of digital manufacturing systems within a highly regulated biopharmaceutical environment. Your responsibilities will include:
• Translate manufacturing, process and user needs into clear functional requirements, workflows and system specifications.
• Collaborate with system engineers, technical experts and external vendors to ensure appropriate system configuration and implementation.
• Support the design, configuration and optimisation of digital manufacturing systems, including Manufacturing Execution Systems (MES) and enterprise applications.
• Work closely with manufacturing, process experts, Quality Assurance, Engineering and IT to develop effective system solutions.
• Ensure critical process, product, data integrity and compliance requirements are incorporated into system designs.
• Support system changes and new functionalities in accordance with established change control and validation procedures.
• Prepare and review functional specifications, test protocols, qualification documents, SOPs and work instructions.
• Execute system testing, including User Acceptance Testing (UAT), while documenting results and ensuring compliance.
• Support validated system implementation, operational readiness and handover to end users.
• Develop training materials and provide training to end users on implemented systems.
• Support system interfaces, data flows and integration between connected manufacturing applications.
• Contribute to standardisation, scalability and continuous improvement of digital solutions.

Requirements:
• Bachelor’s or Master’s degree in Biotechnology, Bioengineering, Pharmacy, Industrial Automation, Computer Science, Electromechanics or a related scientific or technical field.
• Minimum 1.5 years of relevant professional experience, preferably within a manufacturing, engineering or life sciences environment.
• Experience or strong affinity with digital manufacturing systems, computerised applications and automation technologies.
• Knowledge of business process modelling, business analysis and translating operational requirements into functional specifications.
• Familiarity with Manufacturing Execution Systems (MES) and enterprise software applications.
• Good understanding of manufacturing processes and their interaction with quality, maintenance, testing and engineering.
• Knowledge of GMP principles and working within a regulated environment is an advantage.
• Experience with computerised system validation, system testing or User Acceptance Testing is beneficial.
• Experience with MES configuration, system integration or systems engineering is an advantage.
• Experience within a cell and gene therapy manufacturing environment is a plus.
• Strong analytical thinking, problem solving skills and a pragmatic approach.
• Ability to work independently, manage multiple priorities and adapt to changing project requirements.
• Excellent communication and interpersonal skills with a strong focus on teamwork.
• Quality driven mindset with attention to detail, compliance and continuous improvement.
• Proactive attitude, willingness to learn and ability to collaborate effectively with multidisciplinary teams.
• Professional working proficiency in English is required. Dutch or French is an advantage. Are you ready to make a real difference in healthcare? Join our dynamic team and help drive innovation in medical devices. Apply now and let’s make an impact together Want to learn more? Discover all opportunities at www.mindcapture.com. If MindCapture sees a potential fit, we’ll get in touch as soon as possible. If 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 gladly keep

your profile
in mind for future roles that could suit you better.